minutes of 229th meeting of central licensing board of... · 2 minutes of 233rd meeting of central...
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1
MINUTES OF 233rd
MEETING OF
CENTRAL LICENSING BOARD
HELD ON
30TH
- 31ST
DECEMBER, 2013.
A. LICENSING DIVISION
Item
No. Description
1. Confirmation of the Minutes of 232nd
Meeting
2. Grant of New Drug Manufacturing Licenses
3. Grant of Additional Sections
4. Grant of Renewal of Drug Manufacturing License
5. Miscellaneous Cases
6. Any other item with permission of Chair
B. QUALITY CONTROL
Item
No. Description
1. Quality Control Cases
C. QUALITY ASSURANCE
Item
No. Description
1. Quality Assurances Cases of GMP
DIVISION OF DRUG LICENSING
DRUG REGULATORY AUTHORITY OF PAKISTAN
ISLAMABAD.
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MINUTES OF 233rd
MEETING OF CENTRAL LICENSING BOARD
HELD ON 30-31st DECEMBER, 2013.
233rd
meeting of the Central Licensing Board (CLB) was held on 30-31st December, 2013
in the committee room of Ministry of National Health Services, Regulation & Coordination,
Islamabad under the Chairmanship of Mr. Faqeer Muhammad Shaikh, Director Drug Licensing,
DRAP, Islamabad.
Following members attended the meeting: -
Sr. # Name & Designation Status
1. Mr. Faqeer Muhammad Shaikh, Director, Drug Licensing,
DRAP, Islamabad.
Chairman
2.
A.Q Javed Iqbal, Director (QA), as representative of
Division of Quality Assurance and Laboratory Testing,
DRAP, Islamabad.
Member
3.
Mr. Ayaz Ali Khan, Chief Drug Controller, Department of
Health, Govt. of Punjab. (Mr. Muazzam Ali Khan, Secretary, PQCB, Punjab, Lahore attended
the meeting on behalf of Ayaz Ali Khan)
Member
4. Mr. Qaiser Muhammad, Chief Drug Inspector, Department
of Health, Govt. of Sindh.
Member
5. Mr. Atta-Ur-Rehman, Chief Drug Inspector, Department
of Health, Govt. of Baluchistan.
Member
6. Dr. Syed Jamshed Kazmi Member
7. Syed Muid Ahmed Member
8. Syed Jawed Yousaf Bukhari Member
9. Prof. Dr. Gul Majeed Khan, Chairman, Department of
Pharmacy, Quaid-e-Azam University, Islamabad.
Member
10. Prof. Dr. M. Saeed, Department of Pharmacy, University
of Peshawar, KPK.
Member
11. Mr. Abdullah, Deputy Director General (Lic.), DRAP,
Islamabad.
Secretary
12. Mr. Khawaja Javed Akbar, Representative of PPMA. Observer
13. Mr. Nadeem Alamgir, Representative of Pharma Bureau. Observer
14. Mr. Asif Akhai, Representative of PCDA Observer
The Chairman CLB welcomed the honorable members of this Apex Forum & participants of the
meeting. The meeting started with the recitation of verses from the Holy Quran. The Chairman
and the members of the Board briefly introduced themselves.
The Chairman apprised the members of the Board that proceedings of CLB shall be conducted in
an amicable and responsible way to deliver to the public and stake holders in a transparent and
efficient manner. He further added that all the legal and codal formalities regarding convening of
the meeting have been fulfilled.
Dr. Ahmed Mehmood Mumtaz, CQC/DDG (E&M), Mr. Khalid Mahmood, DDC (Lic.), Mr.
Zaheeruddin M. Baber DDC (Q.C.), Mr. Adnan Faisal Saim, DDC (Q.A.) and Mr. Salateen
Waseem Philip ADC (Lic.) DRAP Islamabad assisted the Secretary CLB in presenting the
agenda.
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2. Secretary CLB presented the agenda and started proceedings of the Board as follows:-
A. LICENSING DIVISION
Item No.1 CONFIRMATION OF THE MINUTES OF 232nd
MEETING
The Central Licensing Board confirmed the minutes of 232nd
meeting held on 29th
& 30th
July, 2013.
Item No. 2 GRANT OF NEW DRUG MANUFACTURING LICENSES.
The Board decided the following cases of Grant of Drug Manufacturing License in the light of
recommendations by respective panel of experts/inspectors.
S No. Name of the firm Type of
License Decision of CLB
1. M/s Cotton Craft
(Pvt) Ltd., Ltd., Plot
No. 407- Sunder
Industrial Estate,
Lahore.
(DML No. 000227)
Formulation
Approved the Grant of DML at New Site with
same DML No. (DML No. 000227) subject to
cessation of manufacturing operations and
surrendering of existing DML to DRAP (CLB-
Statutory Body) at present premises situated at 12-
KM Multan Road, Canal View Society, Lahore.
Board approved the following Sections: -
Sections (09) 1. Absorbent Cotton Wool.
2. Plaster of Paris Bandages.
3. Gauze Swabs/ Ribbon Gauze Section.
4. Gauze Roll / Absorbent Lint Section.
5. Eye Pad Section.
6. Paraffin Gauze Dressing /
Para-Tulle Dressing / Poly Grass
Dressing.
7. Bandages Section.
8. Cotton Crepe Bandages Section.
9. Lap Sponges Section.
2. M/s Wellness
Pharmaceuticals
(Pvt) Ltd., Plot No.
33, Sunder Industrial
Estate, Lahore.
Formulation
Approved the Grant of DML
with following Sections: -
Sections (04)
1. Tablet (General).
2. Capsule (General).
3. Oral Liquid (General).
4. External Preparations.
3. M/s Stallion
Pharmaceuticals,
(Pvt) Ltd, Sunder
Industrial Estate,
Lahore.
Formulation
Approved the Grant of DML
with following Sections: -
Sections (03)
1. Capsule (Penicillin)
2. Dry Powder Suspension (Penicillin)
3. Dry Powder Injection (Penicillin)
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4. M/s Umema Pharma,
Plot No. 28, Hub
Industrial Estate,
Hub, Balochistan.
Formulation
Approved the Grant of DML
with following Sections: -
Sections: (02)
1. Tablet (General)
2. Capsule (General)
5. M/s Hiranis
Pharmaceuticals
(Pvt) Ltd, Plot No. E-
145 to E-149, North
Western Industrial
Zone, Port Qasim,
Karachi.
Formulation
Approved the Grant of DML
with following Sections: -
Sections: (16)
1. Tablet (General)
2. Capsule (General)
3. Dry Powder Suspension (General)
4. Liquid Syrup (General)
5. Mouth Wash (General)
6. Sachet (General)
7. Liquid Sachet (General)
8. Effervescent Tablet (General)
9. Toothpaste (Medicated)
10. Cream/Ointment / Gel (General)
11. Cream/Ointment (Steroid)
12. Tablet (Steroid)
13. Capsule (Steroid)
14. Liquid (Steroid)
15. Capsule (Probiotics)
16. Sachet (Probiotics)
The Board desired to get clarification from the
firm regarding Liquid Sachet (General) dosage
form and its proof of availability in developed
countries before issuance of approval letter for
this section.
6. M/s. Cibex (Pvt) Ltd,
F-405, SITE,
Karachi.
Formulation
Approved the Grant of DML
with following Sections: -
Sections: (09)
1. Tablet (General)
2. Capsule (General)
3. Sachet (General)
4. Tablet (General Antibiotic)
5. Capsule (General Antibiotic)
6. Dry Syrup (General Antibiotic)
7. Ointment-I (Steroids)
8. Ointment-II (Non Steroids)
9. Liquid Manufacturing Mr. Javed Yousuf Bukhari (Memebr CLB) and also member of the inspection panel apprised the
Board about unprofessional attitude of Mrs. Roohi Obaid (one of the members of said panel)
during inspection proceedings.
The Board discouraged such attitude of inspectors during the panel inspections. The Board directed
that in case a member intends to write a note of dissent with regard to inspection, the same must be
written on the panel report, instead of submitting the note of dissent separately.
The Board further decided that in case, if the majority of members of panel recommend the grant of
new DML / Renewal of DML / Additional Section(s), the Board may consider such
recommendations if deem appropriate, keeping in view the safety of public health at large.
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7. M/s Ameer & Adnan
Pharmaceuticals
(Pvt) Ltd,
47-Sunder Industrial
Estate, Lahore.
Formulation
Approved the Grant of DML
with following Sections: -
Sections: (03)
1. Tablet (General)
2. Capsule (General)
3. Injectable General (Ampoule/Vial/Low
Volume infusion)
The Board directed to get clarification from firm
regarding Injectable General Section before
issuance of approval.
8. M/s Lasani Health
Care, Plot No.29-
A/RI, Industrial
Estate, Gadoon
Amazai, Sawabi,
KPK.
Formulation
Approved the Grant of DML
with following Sections: -
Sections: (03)
1. Disposable Syringes
2. IV Infusion Set
3. IV Cannula
9. M/s. Wimits
Pharmaceuticals,
129-Sunder Industrial
Estate, Lahore.
Formulation
Approved the Grant of DML
with following Sections: -
Human Sections
Sections: (03)
1. Syrup (General Human).
2. Tablet (General Human).
3. Capsulation (General Human).
Veterinary Sections
Sections: (05)
1. Veterinary Liquid Injection (General)
2. Veterinary Drench General)
3. Veterinary Aerosol (General)
4. Veterinary Oral Powder (General).
5. Veterinary Bolus (General)
10. M/s Wenovo
Pharmaceuticals, Plot
No. 31&32, Punjab
Small Industrial Estate,
Taxila, Rawalpindi.
Formulation
Approved the Grant of DML
with following Sections: -
Sections (05)
1. Tablet.
2. Capsule.
3. Dry Powder for Suspension (General).
4. Sachet (General).
5. Capsule (Cephalosporin).
11. M/s Agror Pharma
(Pvt) Ltd, Plot No. 4, St
No. SS-4 National
Industrial Estate,
Rawat, Rawalpindi.
Formulation
Approved the Grant of DML
with following Sections: -
Sections (03)
1. Dry Powder Suspension (Cephalosporin).
2. Capsule (Cephalosporin).
3. Dry Powder for Injection (Cephalosporin).
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12. M/s Nortech
Pharmaceuticals, Plot
No. 203, Industrial
Triangle, Kahuta Road,
Islamabad.
Formulation
Approved the Grant of DML
with following Sections: -
Sections (05)
1. Tablet General
2. Capsule General
3. Dry Powder Suspension
4. Cream/ Ointment /Gel (Non Steroidal).
5. Ampoule/ vial
The Board advised to get clarification from firm
regarding Ampoule/Vial Section before
issuance of approval.
13. M/s Ravi Medical
Supplies (Pvt) Ltd,
Pahian Road, Raiwind
Distt. Kasur.
Formulation
Approved the Grant of DML
with following Section: -
Section (01)
1. Disposable Syringes (3cc,5cc&10cc only)
The Board also Directed to ask area FID to submit a
report on calibration / validation data (both equipment
& processes etc) during active production.
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Item No.3 GRANT OF ADDITIONAL SECTIONS.
The Board decided the following cases of Grant of Additional Sections in the light of
recommendations by respective panel of experts/inspectors.
S No. Name of the firm Type of
License Decision of CLB
1. M/s Bosch Pharmaceuticals
(Pvt) Ltd, Karachi
Formulation
Approved the Grant of following
Additional Sections: -
Sections (05) 1. Tablet (Cephalosporin).
2. Dry Powder Suspension
(Cephalosporin).
3. Capsule (Cephalosporin).
4. Packing Area (Cephalosporin).
5. Lyophilized Powder Vial Filling
2. M/s UDL Pharmaceuticals,
Port Qasim, Karachi.
Formulation
Approved the Grant of following
Additional Sections: -
Sections (02) 1. Capsule (General).
2. Dry Powder Suspension
(General).
3. M/s Candid Pharmaceuticals,
Opp. Pasrur Sugar Mills,
Sialkot
Formulation
Approved the Grant of following
Additional Sections: -
Sections (03)
1. Capsule (General).
2. Dry Powder Injectable
(Cephalosporin).
3. Dry Powder Suspension
(Cephalosporin).
4. M/s Mac&Rains
Pharmaceuticals (Pvt) Ltd,
Manga Mandi, Lahore.
Formulation
Approved the Grant of following
Additional Sections: -
Sections: (08)
1. Tablet (General)
2. Capsule (General)
3. Sachet (General)
4. Dry Suspension (General)
5. Liquid Injectable Vial (General)
6. Liquid Injectable Ampoule
(General).
7. Cream/Ointment (General)
8. Eye Drops (General)
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5. M/s Sharooq Pharmaceuticals
(Pvt) Ltd, Lahore
Formulation
Approved the Grant of following
Additional Section: -
Section (01)
1. Cream/Ointment steroid Section
The Board showed its displeasure
with respect to casual reporting
by the panel by skipping clear
rating.
6. M/s Mallard Pharmaceuticals
(Pvt) Ltd, Lahore.
Formulation
Approved the Grant of following
Additional Sections except
repacking for ephedrine HCl &
ephedrine sulphate as laid down
under Schedule-D: -
Sections (02)
1. Powder (Repacking)
2. Liquid (Repacking)
7. M/s Medisearch Pharmacal
(Pvt) Ltd, Lahore.
Formulation
Approved the Grant of following
Additional Sections: -
Sections (03)
1. Dry Powder Suspension
(General).
2. Dry Powder Suspension
(Cephalosporin).
3. Capsule (Cephalosporin).
8. M/s Searle Pakistan Limited,
Lahore.
Formulation
Approved the Grant of Additional Section
namely Tablet (General) subject to following
conditions that: -
Newly established QC Laboratory shall be
used as in-process QC Laboratory (for
products to be manufactured in Block-2)
whereas, the already established QC
Laboratory of Block-1 shall be used as main
laboratory for QC of all the registered products
of the firm (for products to be manufactured in
Block-1& Block-2)
The Board as per undertaking of the firm
endorsed the block-wise arrangement for
manufacturing of products.
The Board however, did not accede to the
undertaking of the firm for surrendering the
capsule (General) section (Layout Plan recently
approved) and utilizing the said area for tablet
section.
Board further directed the firm to submit proper
application for withdrawal of Capsule (General)
section and utilizing the same area for tablet
section as per laid down procedure.
The Board authorized its Chairman to dispose-
off the case after verification of above
conditions /compliance accordingly.
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9. M/s Healthtek (Pvt) Ltd, Plot
No. 14, Sector 19, Korangi
Industrial Area, Karachi.
Formulation
Approved the Grant of following
Additional Section: -
Section (01)
1. Liquid ampoule (water for
injection with diluents).
Board further approved the
verification of changes in the
existing building as under: -
1. Development of Microbiology
Laboratory
2. Secondary Packaging area for
ampoule and vials.
3. Some changes in personnel and
material flow. Addition of air
curtains, air lock improved the
area classifications.
Mr. Javed Yousuf Bukhari (Memebr CLB) and also member of the inspection panel
apprised the Board about unprofessional attitude of Mrs. Roohi Obaid (one of the members
of said panel) during inspection proceedings.
The Board discouraged such attitude of inspectors during the panel inspections. The Board
directed that in case a member intends to write a note of dissent with regard to inspection,
the same must be written on the panel report, instead of submitting the note of dissent
separately.
The Board further decided that in case, if the majority of members of panel recommend the
grant of new DML / Renewal of DML / Additional Section(s), the Board may consider such
recommendations if deem appropriate, keeping in view the safety of public health at large.
10. M/s Sunrise Pharma (Pvt) Ltd,
A-594, Sunder Industrial
Estate, Lahore.
Formulation
Approved the Grant of following
Additional Section: -
Section (01)
1. Dry Powder Injectable
(Cephalosporin)
11. M/s Brookes Pharma (Pvt)
Ltd, Karachi.
Formulation
Approved the Grant of following
Additional Sections: -
Section (2)
1. Dry Powder Injectable
(Cephalosporin)
2. Sterile Liquid Ampoule
(expansion)
12. M/s. Wise Pharmaceuticals,
Rawat, Rawalpindi.
Formulation
Approved the Grant of following
Additional Sections: -
Sections (02)
1. Sterile Liquid Ampoule
2. Small Volume Parenteral
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13. M/s. Decent Pharma,
Rawat, Rawalpindi.
Formulation
Approved the Grant of following
Additional Sections: -
Sections (01)
1. Liquid Injection General (Vet.)
14. M/s Jasons Pharmaceuticals, Plot
No. 26, Street No. SS-2, National
Industrial Zone, Rawat,
Islamabad.
Formulation
Rejected the grant of additional
section of liquid ampoule (General)
on the basis of unsatisfactory
conditions of the section.
15. M/s Sharooq Pharmaceuticals
(Pvt) Ltd, Lahore
Formulation
Approved the Grant of following
Additional Sections: -
Sections (02)
1. Injection (General)
2. Vial Infusion
Injection (General) Section is not clear
whether it is Vial or Ampoule, so
Board advised to get clarification from
firm/area FID before issuance of
approval.
The Board showed its displeasure with
respect to casual reporting by the panel
by skipping clear rating.
16. M/s Sanofi Aventis Pakistan
Limited Karachi. DML No.
ooooo7 (Formulation)
Formulation Approved the Grant of following
Additional Section: -
Section (01).
Primary & Secondary Packaging Areas.
17. M/s Care Pharmaceuticals 8-
KM, Thokar Raiwind Road,
Lahore
Formulation Approved the Grant of following
Additional Section: -
Section (01)
1. Oral Liquid (General)
The Board showed its displeasure
with respect to casual reporting by the
panel by skipping clear rating.
18. M/s Novartis Pharma (Pakistan)
Ltd, West Wharf Road, Karachi
DML No.000193 (Formulation).
Formulation Approved the Grant of following
Section: -
Section (01)
1. Capsule (General)
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Item No.4 GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE.
The Board decided the following cases of Grant of Renewal of Drug Manufacturing License in
the light of recommendations by panel of experts/inspectors subject to confirmation of
installation of HVAC system and updated deposition of CRF admissible under the rules.
S No. Name of the firm Type of
License Decision of CLB
1 M/s Venus Pharma, Multan
Road, Lahore.
Formulation
Approved the Grant of Renewal of
DML.
2 M/s Heal Pharmaceuticals (Pvt)
Ltd, Peshawar F
Formulation Approved the Grant of Renewal of
DML.
3. M/s Frontier Dextrose Ltd,
Hattar
Formulation
Approved the Grant of Renewal of
DML.
4. M/s Global Pharmaceutical,
Kahuta Triangle, Islamabad
Formulation
Approved the Grant of Renewal of
DML.
5. M/s Kailgon Agro Industries
(Pvt) Ltd District Lasbella
Balochistan.
Formulation
Approved the Grant of Renewal of
DML except for sterile injection section.
6. M/s Gelcaps (Pakistan) Ltd, Plot
No. B, HITE, District Lasbela
Balochistan.
Semi Basic
Approved the Grant of Renewal of
DML.
7. M/s Sultan Cotton & Bandages,
Sindh Small Industrial Estate,
Mirpurkhas.
Formulation
Approved the Grant of Renewal of
DML.
8. M/s Candid Pharmaceuticals,
Opp. Pasrur Sugar Mills, Sialkot.
(DML No. 000450)
Formulation
Approved the Grant of Renewal of
DML.
9. M/s Mediways International, 16-
KM, Multan Road, Lahore.
Formulation
The Board did not allow the waiver of
minimum plot size (i.e. total plot size 1
Kanal and 3 marlas) so deferred the
renewal of DML and decided to strictly
adhere to the provision of Schedule-B of
Drugs (LR&A) Rules, 1976.
The Board further decided to issue
Show Cause Notice and Personal
Hearing in the next meeting of CLB.
10. M/s BSN Medical (Pvt) Ltd, plot
No, A/69, S.I.T.E Karachi.
Formulation
The Board suspended the manufacturing
license (Formulation) in all areas for a
period of three months under Rule 13 of
Drugs (Licensing, Registering and
Advertising) Rules, 1976 for
rectification of observations made
during the inspection by the panel.
The Board further decided to issue
Show Cause Notice and Personal
Hearing in the next meeting of CLB for
repeated non-compliance of GMP.
12
11. M/s Mallard Pharmaceuticals
(Pvt) Ltd, Lahore.
Formulation
Approved the Grant of Renewal of
DML.
12. M/s Attabak Pharmaceuticals,
Industrial Area, Islamabad.
Formulation
Approved the Grant of Renewal of
DML.
13. M/s Vetec Laboratory, Industrial
Area Kahuta Triangle,
Islamabad.
Formulation
Approved the Grant of Renewal of
DML.
14. M/s Legacy Pharmaceutical
(Pvt) Ltd, Industrial Estate,
Hayatabad.
Formulation
Approved the Grant of Renewal of
DML.
15. M/s Uniferoz (Pvt), Karachi.
The file is submitted for perusal / guidance with the recommendations that the case may be submitted before CLB in its forthcoming meeting to solicit wisdom of the CLB, with the proposal that the objections / paramenters raised by one of the panel member carry weightage
Formulation
Approved the Grant of Renewal of
DML.
Mr. Javed Yousuf Bukhari (Memebr CLB) and also member of the inspection panel
apprised the Board about unprofessional attitude of Mrs. Roohi Obaid (one of the members
of said panel) during inspection proceedings.
The Board discouraged such attitude of inspectors during the panel inspections. The Board
directed that in case a member intends to write a note of dissent with regard to inspection,
the same must be written on the panel report, instead of submitting the note of dissent
separately.
The Board further decided that in case, if the majority of members of panel recommend the
grant of new DML / Renewal of DML / Additional Section(s), the Board may consider
such recommendations if deem appropriate, keeping in view the safety of public health at
large.
16. M/s Healthtek (Pvt) Ltd,
Karachi.
Formulation
Approved the Grant of Renewal of
DML.
Mr. Javed Yousuf Bukhari (Memebr CLB) and also member of the inspection panel
apprised the Board about unprofessional attitude of Mrs. Roohi Obaid (one of the members
of said panel) during inspection proceedings.
The Board discouraged such attitude of inspectors during the panel inspections. The Board
directed that in case a member intends to write a note of dissent with regard to inspection,
the same must be written on the panel report, instead of submitting the note of dissent
separately.
The Board further decided that in case, if the majority of members of panel recommend the
grant of new DML / Renewal of DML / Additional Section(s), the Board may consider
such recommendations if deem appropriate, keeping in view the safety of public health at
large.
17. M/s Macter international (Pvt)
Ltd, E-40, S.I.T.E Karachi.
(DML No. 000641)
Formulation
Approved the Grant of Renewal of
DML.
18. M/s. Wise Pharmaceuticals,
Rawat, Rawalpindi.
Formulation
Approved the Grant of Renewal of
DML.
19. M/s. Zafa Pharmaceuticals
Laboratories (Pvt) Ltd.,
Federal B. Industrial Area,
Karachi.
Formulation
Approved the Grant of Renewal of
DML.
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20. M/s. Zafa Surgitex,
Plot No. A/421, SITE,
Nooriabad, Sindh.
Formulation
Approved the Grant of Renewal of
DML.
21. M/s Novartis Pharma (Pakistan)
Ltd, West Wharf Road, Karachi
DML No.000193 (Formulation)
Formulation
Approved the Grant of Renewal of
DML.
22. M/s Paktex Industries, 2.5 KM,
Tatlay Road, Sroya Abad
Kamonke, District Gujranwala.
Formulation
Approved the Grant of Renewal of
DML.
23. M/s Risma Laboratories, A-28,
S.I.T.E, Karachi
DML No. 000053 (Formulation)
Formulation
The Board suspended the
manufacturing license
(Formulation) in all areas for a
period of three months under Rule
13 of Drugs (Licensing,
Registering and Advertising)
Rules, 1976 for rectification of
observations made during the
inspection by the panel.
The Board also did not accede to
the recommendations of panel for
manufacturing of External
Preparations for export purpose in
the light of rule 17(2) of Drugs
(LR& A) Rules, 1976.
The Board further decided to issue
Show Cause Notice and Personal
Hearing in the next meeting of
CLB.
24. M/s Nimrall Laboratories, Plot No.
24, St. No. SS-3, National Industrial
Estate, Rawat, Rawalpindi.
Formulation
Approved the Grant of Renewal of
DML.
25. M/s Amson Vaccine & Pharma
(Pvt) Ltd, Plot No. 113, Industrial
Triangle Kahuta Road, Islamabad.
Formulation
Board suspended the manufacturing
license (DML No.000638-Formulation) in
all areas for a period of one month
under Rule 13 of Drugs (Licensing,
Registering and Advertising) Rules,
1976 for rectification of observations
made during the inspection by the
panel.
The Board further decided to issue
Show Cause Notice and Personal
Hearing in the next meeting of CLB.
26. M/s Hygeia Pharmaceuticals, Plot
No. 295, Industrial Triangle,
Kahuta Road, Islamabad.
Formulation
Approved the Grant of Renewal of
DML.
14
Item No.5 MISCELLANEOUS CASES.
Case No.1 Establishment of a Pharmaceutical Unit - M/S Pharmedic Chemical, 24-KM,
Multan Road, Lahore.
M/s Pharmedic Chemical, Lahore has submitted an application for the Drug Manufacturing
License by way of Semi Basic Manufacturing at 24 KM Multan Road, Mohlanwal, Lahore. The
proceedings of the above application is as under:-
1. Area FID, Lahore was requested for site inspection on 10th
December, 2012.
2. Mr. Ajmal Sohail Asif, Area FID inspected the site on 13th
December, 2012, the finding
of inspection are as under:
a. It was observed, astonishingly, that the said site has already been constructed. The
pharmaceutical unit to manufacture drugs by way of semi-basic manufacturing
has already been established. There was a double story building, having large
halls in which the machinery for semi-basic manufacturing has been installed. At
few placed some civil work was going on.
b. The management was inquired about the status of the site. The management was
asked that why the building has been constructed prior to the approval of the site
and layout as per the Drugs Act, 1976 and rules framed under. Mr. Ejaz Hussain,
General Manger informed that they have already got approval of the site and
layout few years back but unfortunately the file has been lost by the licensing
section of the DRAP Islamabad. He was asked to provide firm’s own copies of
the said approval so that the lost file may be reconstituted and concerned authority
may be approached for further necessary action under the law. He assured to
provide the copies to the undersigned on 17-12-2012. But the management of the
firm failed to provide the documents as per their claim.
c. Moreover, it was observed that in front of the site/unit (about 100 meters from
the main gate of the unit) there passes a very large sewerage drain (Rajbah/Ganda
Nala) that may pose serious environmental hazard to the site/unit.
d. From the above mentioned situation it appears that the firm has established the
pharmaceutical unit without fulfilling the codal formalities as required under the
Drugs Act, 1976 and riles frame there under.
e. Submitted for perusal, further necessary action and direction, please.
3 Mr. Ajmal Sohail Asif, Area FID was again asked on 23rd
January, 2013 for clear for
clear recommendations regarding approval of site. FID in his letter of 29th
January, 2013
furnished following recommendations:
a. In the light of physical inspection of the site in observations made site is not
suitable for established of a pharmaceutical unit as per requirement laid down
under paragraph 1 of section 1 of the Schedule “B” (SRO. 470(I)98 dated 15-05-
1998. under rule 16(a) for the Drugs(Licensing, registering & Advertising) Rules,
1976.
4 On 3rd
April, 2013 another panel comprising of Mr. Jamil Anwar member CLB Lahore
and Ms Ayesha Khalil FID, Lahore was requested for re-inspection of the site.
Accordingly Ms Ayesha Khalil Area FID conducted inspection on 24-07-2013 alone as
15
another member of the panel Mr. Jamil Anwar did not join after giving time for the said
inspection a no response has bee received from his cell phone even after repeated call.
a. The total area of the land was 26 kanal. A semi basic manufacturing plant was
already constructed. In the main building machinery for semi basic manufacturing
was installed. Total six buildings comprising of boiler room, raw material store,
workshop, compressor room, officer and manufacturing plant i.e. main building
were situated in the area.
b. Towards south i.e. in front of the site a sewerage drain passes and the
management informed that due to large amount of waste disposal i.e.
approximately 25 tons/3 hours owing to semi basic manufacturing this large
sewerage drain is very useful as they intend to dispose off their waste in the drain.
Moreover, the firm has also provided an environmental monitoring report
conducted by the Environmental Services SGS Pakistan (Pvt) Ltd for ambient air
quality monitoring, metrological conditions and in door air quality monitoring.
c. On the North, East and West side there were agricultural lands, on the South
sewerage drain.
d. Mr. Iftikhar Sheikh informed that he was not aware that a site approval is required
for semi-basic manufacturing unit; hence he has done heavy investment in
building a semi basic manufacturing facility.
e. Attested copy of sketch of the plot and adjoining areas and other legal documents
such as copy of registry etc provided.
f. Conclusion: Keeping in view the above facts/observations, M/s Pharmedic
Chemicals 24-KM, Multan Road, Mohalanwal, Lahore is a semi basic
manufacturing facility built without prior site approval as required under the rules,
the firm has also provided report of SGS which shows that the ambient air quality
is within the limits, Hence to save huge investment and to encourage semi basic
manufacturing the firm may be granted ex-post facto approval for site, for the
purpose the case may be referred to Central Licensing Board.
5. Submitted for consideration and order of the Board please.
Decision of CLB: -
The Board after thorough deliberations and keeping in view the rule position
rejected the application of Site under Schedule-B (1.2)&(2) of Drugs (Licensing,
Registering and Advertising) Rules, 1976.
16
Case No.2 Policy Matter Regarding Grant of Cases / Layout Plans of Additional
Sections for Psychotropic / Narcotic Drugs pending / deferred.
The Central Licensing Board in its 232nd
meeting held on 29-30 July, 2013 considered
the above case and decided as under: -
( Extracts of 232nd
meeting are reproduced as under )
GRANT OF CASES / LAYOUT PLANS OF ADDITIONAL SECTIONS FOR
PSYCHOTROPIC / NARCOTIC DRUGS PENDING / DEFERRED.
The Central Licensing Board in its 227th
meeting deferred the approvals of Psychotropic /
Narcotic sections of all the firms placed on the agenda till recommendation of the inter-
ministerial committee specifically constituted for Psychotropic/Narcotic Drugs. The concerned
section of Narcotic / Psychotropic / Controlled Drugs of DRAP has informed that the subject
case was placed before the 11th
meeting of the committee on allocation of the controlled drugs
under Ministry of National Narcotics Control held on 6th
May 2013 and forwarded the extract of
the minutes of the meeting which is being reproduced as under: -
“The Committee decided that CLB may consider the Licensing and approval of additional
sections for manufacture of controlled drugs/substances in the light of relevant Act and rules.
The Committee on Allocation of Controlled Drugs will consider matter for allocation of
Controlled Drugs in the light of relevant laws and rules after registration”.
DECISION OF CLB.
The Board after taking into consideration all pros and cons of the matter and taking in
account decision of meeting of Inter-Ministerial Committee on allocation of the controlled
drugs, decided to withheld / defer the cases for approval of layout plans and grant of
additional sections for Psychotropic / Narcotics Drugs due to the following reasons: -
The Board decided to send a reference regarding the above mentioned decision to
Director Controlled Drugs, DRAP with the recommendations of CLB to take up the
matter with Ministry of National Narcotics Control on following issues as the Central
Licensing Board is of opinion that clarification is required to be solicited to proceed
further in to the matter.
There is no provision under the Drugs Act, 1976 and rules framed there under to process
the cases for approval of Building Layout plans & sections / additional sections for
production of Psychotropic / Narcotic drugs.
The above mentioned decision of the Inter Ministerial Committee and previous
decisions of CLB & DRB need to be revisited as most of the CLB members attending
the meeting were of view that as per international practice there is no need of segregated
/ dedicated facility for manufacturing of Psychotropic / Narcotic products.
The members of CLB namely Mr. Salim Isharat Husain, Mr. Khalid Yousuf, Syed
Jawed Yousaf Bukhari, Dr. Ali Akbar Sial and Mr. Nadeem Iqbal were of view to grant
approval of Psychotropic/Narcotic drugs in general sections since: -
i. No Separate Area is required for manufacturing of Solids or Liquids
Psychotropic / Narcotics Dugs in other countries including WHO, FDA USA,
FDA India etc., hence why should we put extra burden on our manufacturers for
17
dedicated areas with dedicated HVACs.
ii. Cross Contamination in the world is handled by Robust Systems and Validation /
Cleaning Validation etc. for Psychotropic / Narcotic substances. Even the API’s
of Psychotropic / Narcotics are manufactured in General Sections in the world.
iii. Only Beta Lactams. Cephalosporin, Anabolic Steroids, etc. requires dedicated
facilities.
However members of CLB, Mr. Ayaz Ali Khan, Chief Drugs Controller, Health
Department, Govt. of Punjab, Prof. Gul Majeed Khan, and Mr. Ahmad Din Ansari,
Secretary CLB were of view that there must be some more deliberations on the subject
issue and policy of dedication / segregation of Psychotropic / Narcotic drugs may not be
discontinued with one pen stroke. Furthermore CL&RB in its 184th
meeting held on 23-
08-2004 “decided to allow the firms upto 31st December 2005 to establish segregated
facilities for Psychotropic / Narcotic Drugs. However, during this period they may
manufacture both categories of drugs in their previous facilities but after this period
complete shift over to segregated facilities shall be mandatory otherwise they have to
surrender their registrations for these drugs”. It is further decided that every member of CLB will send his recommendations
supported by documentary evidence for revisiting policy decision sent by the
Directorate of Controlled Drugs in collaboration with Ministry of National Narcotics
Control accordingly.
The representatives from PPMA and Pharma Bureau also agreed to issue approvals of
the deferred cases / sections of Psychotropic/ Narcotic Drugs after receiving the fresh
reference from Directorate of Controlled Drugs as stated above.
FURTHER PROCEEDINGS ON THE MATTER
The issue of Psychotropic / Narcotic drugs has witnessed the discussions at various
forums. The details of the same are presented here before the Board for its perusal and
discussion, so that it can reach an appropriate decision.
1. Decision of Committee on Controlled Drugs dated 6th
May, 2013
The Committee on Controlled Drugs decided that:
“The CLB may consider the licensing and approval of additional sections for
manufacture of controlled drugs / substances in the light of relevant Act and Rules”.
The Drugs Act, 1976 and rules made there under are silent to consider the requests till
amendments are made in respective rules.
2. Recommendations of International Narcotics Control Board (INCB)
The delegation of International Narcotics Control Board visited Pakistan on 11th
-14th
September, 2012 and gave their observations. The major points highlighted by INCB are
as under: -
i. Weakness and inadequacies in the control of Narcotics / Psychotropic / precursor
chemicals in Pakistan.
18
ii. Misuse of pharmaceutical preparations containing controlled substances, particularly
psychotropic substances, largely due to absence of prescription control at both
pharmacy and doctor’s level.
iii. Lack of improvement with regard to ensuring adequate availability of opioids for
medical purposes.
iv. Increase risk of diversion of precursor chemicals.
v. INCB emphasized the capacity building of Regulatory Authority so that it can
discharge its functions as required under the International Drug Control Treaties, i.e.
To ensure adequate availability of narcotic drugs and psychotropic
substances for medical and scientific purposes,
To prevent their diversion and abuse
To ensure full compliance with Pakistan’s treaty-based reporting obligations.
vi. Pakistan is among few countries in the world with the highest annual legitimate
requirements (ALR) for Ephedrine and Pseudoephedrine.
vii. INCB proposed that UNODC Pakistan and WHO Pakistan may be requested for
assistance in conducting study regarding the issued highlighted above.
3. Minutes of 4th
Meeting of Policy Board
The Policy Board in its 4th
meeting held on 23-10-2013 advised the Director Licensing /
Chairman Central Licensing Board to resolve the issue of dedicated facility for the
manufacturing of Psychotropic drugs, on priority and if that was not the express requirement of
respective rules then the CLB should consider allowing campaign manufacturing as per
international practice.
The DRAP is in acute shortage of human resource with respect to Officers and Officials /
Staff. The provision of campaign manufacturing to observe specific precautions like validations
cannot be ensured with grossly in adequate and rudimentary structure of DRAP. In
circumstances where most of the Drug Inspectors have been failed to inspect the License Unit
twice in a year for GMP inspections under Rule 4 (1)(a) as laid down under the Drugs (Federal
Inspectors, Federal Drugs Laboratory, and Federal Government Analyst) Rules, 1976, how can
FIDs ensure validations on campaign manufacturing.
This step may ultimately lead to a discriminatory / unauthorized permission to some
manufacturer at one hand and may inhibit the natural right of deserving firms on the other hand.
However this provision of campaign manufacturing may be allowed to firms which have their
drugs (Psychotropic / Narcotic Drugs) registered in their name if approved otherwise this open
ended approval may tantamount to misuse the Narcotic / Psychotropic Drugs.
4. Recommendations of 9th
Meeting of DRAP held on 25-11-2013
The DRAP in its 9th
meeting considered the observations made by INCB as mentioned
above and decided to approve that UNODC and WHO Pakistan may be requested for assistance
in conducting study to comply with the observations raised by INCB Mission as above. As such
the recommendations of INCB were endorsed by the DRAP.
19
5. Recommendations of the Members of the CLB
The Central Licensing Board in 232nd
meeting desired that every member of CLB may
send his recommendations supported by documentary evidence for re-visiting policy decision
sent by the Directorate of Controlled Drugs in collaboration with Ministry of National Narcotics
Control accordingly.
Only one member of CLB Mr. Javed Yousaf Bukhari has submitted his recommendations
supported with the documentary evidence where as remaining members have also submitted their
recommendations but without any documentary reference.
Recommendations of Mr. Javed Yousaf Bukhari are as under: -
i. At the initial Phase Grant of Layout plans of Psychotropic Section be allowed after
carefully looking proper HVAC System to facilitate regular supply of the
Psychotropic Drugs.
ii. He recommended to inspect facilities manufacturing Psychotropic Drugs to review
their capabilities and to verify GMP Compliance.
iii. Additional section for Psychotropic Tablet is not economical as low volume of
Psychotropic Drugs is manufactured.
6. Some additional grounds and facts
i. The Drugs Act, 1976 and Rules framed there under are silent to decide the fate of
Psychotropic / Narcotic Drugs in the light of recommendations of the Committee on the
allocation of controlled drugs which is again being reproduced as under: -
“The Committee decided that the CLB may consider the licensing and approval of
additional sections for manufactured of controlled drugs / substances in the light
of relevant Act and Rules”.
ii. An open ended permission of Psychotropic / Narcotic Drugs if granted in General
Sections may greatly hamper the efforts of Federal and Provincial Government to check
an eye on these Drugs and to curb the menace of misuse potential of Psychotropic /
Narcotic Drugs.
iii. Keeping in view of all pros and cons mentioned above, it is proposed that necessary
amendments / additions in the rules may be made prior processing the cases for Narcotic /
Psychotropic / Precursor Drugs to decide the cases in spirit of the decision of Committee
of allocation of Controlled Drugs.
iv. Rule 8(20) of the Drugs (Licensing, Registering & Advertising) Rules, 1976 states as
under: -
“The Central Licensing Board shall follow the policy guidelines of the Federal
Government for the conduct of its business”.
Accordingly, a consensus on the issue of Psychotropic / Narcotic Drugs is necessary and
after getting consensus on the issue, the case may be submitted for approval of Federal
Government, so that the Federal Government may be on Board for taking any decision by
CLB, to avoid any embarrassment.
20
IN ADDITION TO ABOVE, THE BOARD WAS FURTHER APPRISED OF THE
FOLLOWING DELIBERATIONS BEFORE REACHING THE COMPLETE
CONSENSUS FOR MAKING DECISION
1. 191st Meeting of Central Licensing & Registration Board held on 30-31 May, 2005.
The matter of dedicated facilities was placed on the agenda of 191st meeting of CL & RB
held on 30th
– 31st May, 2005 and it was endorsed by the Board that dedicated / self
contained facilities are pre-requisite for the manufacturing of following drugs:-
1. Penicillins
2. Cephalosporin
3. Biologicals
4. Cytotoxic substances
5. Radio Pharmaceuticals
6. Veterinary Immunological Preparations
7. Sterile Preparations
8 Hormonal Preparations.
9. General Antibiotics / Quinolones.
10. Psychotropic / Narcotics.
“The Central Licensing & Registration Board decided to allow the firms up to 31st December,
2005 to establish segregated facilities for “Quinolones” and “Psychotropic / Narcotic” drugs.
However, during this period they may manufacture both categories of drugs in their previous
facilities but after this period complete shift over to segregated facilities shall be mandatory
otherwise they have to surrender their registrations for these drugs”.
2. Ministry of Law & Justice Division in its O.M No.2303/97-Law-I, dated 30-03-2010 had opined
in a reference sent vide letter No.F.1-1/84-Lic, dated 18-01-2010 by defunct Ministry of Health as
under: -
i. We could not find out any provision which enables Central Licensing Board to review its
decision in the Drugs Act, 1976 (XXXI of 1976) and the Drugs (Licensing, Registering and
Advertising) Rules, 1976”. ii. If anybody is aggrieved against the decision of Central Licensing Board, an appeal may be
preferred within sixty days under section 9 of the Drugs Act, 1976(XXXI of 1976).
3. The CLB in its 226th
Meeting held on 31st December, 2010 received a report by a committee
comprising of Mr. Shahid Nasir, Member, CLB, Mr. Jamil Anwar, DTL, Lahore and Dr. Sheikh
Akhtar Hussain DDG, Lahore to analyze the situation and submit their recommendation on
Psychotropic/Narcotic Drugs.
The Brief of report submitted by Committee is as under: -
i. 286 companies are found already manufacturing and marketing Psychotropic/Narcotic
Drugs in various dosage forms.
ii. 446 products are already in the market.
iii. During one year period i.e. in 2010 these companies have sold 42,547,600 units of
various Psychotropic/Narcotic Drugs through retail channels.
21
4. The Central Licensing Board in its 227th meeting held on 1st & 2nd June, 2011
considered and decided as under: -
i. The Board deferred the approval of Psychotropic Production Areas / Sections under
approval by the Licensing Board regarding Capsule, Tablet, Syrup and Injectable etc. till
finalization of recommendations of the Inter Ministerial Committee specifically
constituted for the Psycho Active Drugs.
ii. The firms already having Psychotropic drugs registered with Ministry of Health can
continue with the production of Psychotropic Drugs in segregated areas as requirement
of Schedule B (5.2) of the Drugs Act, 1976.
iii. The Board delegated the power to Chairman CLB for converting Psychotropic sections
(new) into General Sections if the firm desires so. The firm may submit written request
to the Ministry of Health.
5. Recommendations of Committee for Allocation of Controlled Substances/Drugs
(Inter-Ministerial Committee)
The Committee for Allocation of Controlled Substances/Drugs (Inter-Ministerial
Committee) in its meeting held on 6th
May, 2013 decided that:
“Central Licensing Board may consider the licensing and approval of additional sections
for manufacture of controlled drugs / substances in the light of relevant Act and Rules.
The Committee on Allocation of Controlled Drugs will consider matter for allocation of
controlled drugs in the light of relevant laws and rules after registration”.
6. Comments of various members of Board made during the proceeding of meeting
Moazzam Ali Khan (Punjab)
b. Pakistan is 4th
biggest country in the world declared to be using Psychotropic/Narcotic
Drugs.
c. Effective mechanism at manufacturing level needs to be developed.
d. Justification for quota allocation of Psychotropic/Narcotic Drugs needs to be improved.
e. Some mechanism at sale outlets to check the control on these drugs needs to be ensured.
f. Sale of Psychotropic/Narcotic Drugs without prescription should not be allowed.
g. Proper sale record of dispensing of Narcotics / Psychotropic drugs should be maintained.
h. Effective mechanism of controlling Morphine and Pethidine is implemented to prevent
their misuse.
i. Manufacturing of Psychotropic / Narcotic Drugs may be allowed in segregated areas as per
previous decision of the CLB.
Prof. Dr. Gul Majeed Khan (Islamabad)
He endorsed the proper control on Psychotropic/Narcotic Drugs as suggested by Moazzam
Ali Khan (Punjab)
22
Syed Muid Ahmed (Karachi) also emphasized to develop such mechanism to deal with all
matters of Psychotropic/Narcotic Drugs.
Dr. Jamshed Kazmi (Karachi) also supported the justification for controlling / preventing the
misuse of Psychotropic/Narcotic Drugs by applying effective checks at the manufacturing
level in addition to those exercised at the prescription and sale level especially considering
the meager sources of our country. He also supported the opinion of other Board members.
Prof. Dr. M. Saeed (Peshawar) opined to develop stringent control on these drugs.
PPMA and PCDA representatives Mr. Khawaja Javed Akbar and Mr. Asif Akhai
respectively also agreed that manufacturing of Psychotropic / Narcotic Drugs may be allowed
in segregated areas.
Decision of CLB: -
After thorough deliberations and keeping in view the directions of Policy Board,
recommendations of DRAP Authority, recommendations of Committee for Allocation of
Controlled Substances / Drugs (Inter-Ministerial Committee), views of honorable
members, previous decisions of Central Licensing Board on the said issue, and ensuring
adequate availability of narcotic drugs and psychotropic substances for medical and
scientific purposes as highlighted by INCB, the Central Licensing Board decided: -
To continue the previous policy / decisions of Central Licensing Board of segregated
facility for manufacturing of Psychotropic / Narcotic Drugs.
To process all pending layout plans / applications accordingly in the light of above
decision.
To carryout fresh panel inspections of sections / areas of Psychotropic / Narcotic
Drugs considered and deferred in 227th
meeting of CLB.
23
Case No.3 Acquisition of Licensed Premises of M/s Breeze Pharma (Pvt.) Ltd, DML No.
000659 (formulation) by M/s ICI Pakistan Limited on Lease Hold Rights.
The brief background of the case is as under: -
M/s Breeze Pharma (Pvt) Ltd a Licensed Unit intended to lease out their licensed
premises and license to M/s ICI Pakistan Ltd on lease hold rights for a period of ten years. Both
the entities are registered with SECP as a Private Limited Company and a Public Limited
Company respectively. Since there is no provision under the Drugs Act, 1976 & Rules framed
there under to acquire licensed Pharma unit on lease hold rights hence the case was placed before
CLB for consideration/decision in its 232nd
meeting held on 29-30 July, 2013. The Board
accordingly discussed/considered the above case and decided as under: -
“The Board decided to defer the case and desired personal hearing from the owners / directors
of M/s ICI Pakistan Ltd and M/s Breeze Pharma (Pvt.) Ltd to update the CLB on their request
regarding acquisition of licensed premises on lease agreement rights as there is no provision
in Law & Rules to acquire licensed Pharma unit on lease hold rights”.
Since the Drugs Act, 1976 & Rules framed there under do not provide any
provision/remedy in the instant case. Therefore later on the opinion of Law, Justice & Human
Rights Division was solicited in this regard specifically to opine as to whether any licensed unit
registered with SECP and DRAP can be acquired by a non licensed unit by DRAP but registered
with SECP.
The Law Division has furnished its opinion as under: -
2. The instant case relates to application of sub-rule (6) of rule 5 of the Drugs (Licensing, Registering
and Advertising) Rules, 1976, which is reproduced as below:-
“[5(6) For change of the name of a license, fee as prescribed under Schedule ‘F’ for renewal of a
license shall be paid]”.
3. Brief facts of the case are that M/s. Breeze Pharmaceutical having Drug Manufacturing License have
leased out their premises to M/s. ICI Pakistan Limited, which is a non-licensee. Having done that
M/s Breeze Pharma and M/s ICI applied for change of name in the license under the above
reproduced rule. The issue in hand is as to whether M/s. ICI Pakistan Limited require a fresh license
for manufacturing of drugs on the leased premises or license of M/s Breeze Pharmaceutical would be
a valid one for manufacturing of drugs.
4. In this regard it is stated that the license issued by the Competent Authority was issued to the drug
manufacturing facility/manufacturing plant/premises and the inspection prior to granting license was
done for the drugs manufacturing facility, its manufacturing plant, its premises and also of the
qualifications of the management under rules 15 and 16 of the Drugs (Licensing, Registering and
Advertising) Rules, 1976. It would, therefore, be wrong to state that the license was only issued to
the premises and not the management. The collective view of M/s. Breeze Pharma and M/s. ICI is
that only the Board Directors are being changed and not the premises. Attention of both the
companies is invited to section 196 of the Companies Ordinance, 1984, which states that the
business of a company is run and managed by the Directors of a company.
5. In sequel of the above, the Board Directors of a company and the management of a company
are as much important as the premises/machinery/manufacturing facility of a company at the
time of grant of license for manufacturing of drugs. The lease agreement between M/s. Breeze
Pharma and M/s. ICI is more than a mere lease and amounts to transfer of license which is
unauthorized under the said Rules.
24
6. Hence the case does not fall under above reproduced rule 5(6) for change in the name of
license. A fresh license would be required by M/s. ICI for manufacturing of drugs. Before parting
with the file it is pertinent to point out that the referring Division shall suitably amend the Drugs
(Licensing, Registering and Advertising) Rules, 1976 so that such like complications due to silent
position of Rules can be averted in future. Sd/-
(Sheikh Sarfraz Ahmed) Deputy Draftsman-I
28th November, 2013.
The representatives of both the firms have been called for personal hearing in the light of
decision of CLB taken in its 232nd
meeting.
Proceedings: -
The firm was called for personal hearing in the light of decision of CLB taken in its 232nd
meeting. Mr. Abid Puri, the lawyer of both the firms along with Directors / representatives of
both the firms attended the meeting. The point of view of both the firms was heard by the CLB.
The Board was further apprised that: -
1. M/s ICI Pakistan Ltd and M/s Breeze Pharma (Pvt) Ltd are two different entities
as both the firms have different Boards of Directors.
2. It is a case of fresh grant of Drug Manufacturing License and not merely a lease
agreement, as the Drug Manufacturing License is neither transferable nor
heritable.
3. M/s ICI Pakistan Ltd has to apply afresh for grant of DML for which all
requirements as per law need to be fulfilled.
Decision of CLB
The Board after hearing the representatives of M/s. ICI Pakistan Ltd and M/s Breeze
Pharma (Pvt) Ltd. and their legal counsel, thorough discussion and deliberations,
keeping in view the opinion of Law Division and taking in account all pros & cons of the
matter, decided as under: -
M/s. ICI Pakistan Ltd shall apply afresh for grant of DML after surrendering of
License and Inspection Book by M/s Breeze Pharma (Pvt) Ltd.
A fresh resolution in original by the Directors of M/s Breeze Pharma (Pvt) Ltd
and M/s ICI Pakistan Ltd shall be submitted to CLB stating that present
premises of M/s Breeze Pharma(Pvt ) Limited has been acquired/leased out on
leased hold rights by M/s ICI Pakistan Ltd.
The fresh agreement of lease (in original) shall be submitted to CLB by the
acquiring and ceasing Directors of both firms.
The application already submitted along with prescribed fee by M/s. ICI
Pakistan Ltd for grant of fresh DML shall be processed accordingly after
fulfillment of legal formalities and no separate fee shall be required.
The Board waived off the condition of site verification and directed for fresh
panel inspection.
A new DML with new number shall be granted after approval by the Board.
25
Case No.4 Acquisition of Licensed Premises of M/s Mac & Rains (Pvt.) Ltd, Lahore
DML No. 000586 (Formulation) by M/s Searle Laboratories (Pvt.) Limited
on Lease Hold Rights.
The Central Licensing Board in its 232nd
meeting held on 29-30 July, 2013 considered
the request of M/s Searle Laboratories (Pvt.) Limited Karachi on the subject case and decided as
under: -
“The Board decided to defer the case and desired personal hearing from the owners / directors
of M/s Mac & Rains (Pvt.) Ltd, Lahore and M/s Searle Laboratories (Pvt.) Ltd to update the CLB
on their request regarding acquisition of licensed premises on lease agreement rights as there is
no provision in Law & Rules to acquire Licensed Pharma unit on lease hold rights”.
M/s Mac & Rains (Pvt) Ltd have submitted their request for withdrawal of their
application / NOC of acquisition with M/s Searle Laboratories (Pvt) Limited. The firm has
further requested for exemption of personal hearing.
The representatives of both the firms have been called for personal hearing in compliance
of decision of CLB taken in its 232nd
meeting.
Decision of CLB
Board after hearing the representatives of both the firms that they have requested
for withdrawal of their application of acquisition of premises of M/s Mac & Rains (Pvt.)
Ltd, Lahore by M/s Searle Laboratories (Pvt.) Ltd on lease hold rights, acceded to their
request and approved the applications of withdrawal of both the applicants.
Case No.5 Closure of Pharmaceutical Unit of M/s. Vetgro Pharmaceutical (Pvt) Ltd.,
Lahore.
Federal Inspector Drugs, Lahore, has visited M/s Vetgro Pharmaceuticals (Pvt)
Ltd, Multan Road, Lahore on 14-03-2013 and he has stated that firm was found closed. The FID
has reported the following points in its report: -
i) The firm’s three security guards were present at the main gate of the firm. They did
not allow to undersigned to enter the main gate. They stated that they do not have the
keys of the main building (production area). One of them Mr. Zulqarnain informed
that they are employees of a security company and he is appointed here for the last
seven months. He further informed that he does not know about the owners of the
firms and since his duty here the firm was close and no production activity is seen.
ii) Ex Area FID Mr. Asim Rauf had also visited the firm on 01-03-2012 and found the
same status. Letters have also been written to the firm to explain its position in this
regard on 01-03-2012 and 17-05-2012. However, neither any reply received nor any
person contacted even after the lapse of one year.
iii) Undersigned also tried best to contact the Chief Executive of the firm or any other
person responsible but to vain. All the contact numbers landline/mobile as per office
record is either unattended or disconnected. However, it is learnt from some other
26
market competitors that the management has closed the firm due to some
partnership/family disputes.
iv) As it appears from the above submission that the firm is not functional for more than
one year and as non of the owner or any other responsible person is available and as
the premises is not accessible to area FID and as the conditions of the license as per
the Drug (Licensing, Registering and Advertising) Rules, 1976 are not being
maintained. It is recommended that the Drug Manufacturing License bearing No.
000650 dated 30-01-2009 issued in favor of M/s Vetgro Pharmaceuticals (Pvt)
Ltd may be cancelled/ suspended under rule 12 of the Drugs (Licensing,
Registering and Advertising) Rules, 1976.
2. Keeping in view the above, Show Cause notice was issued to the firm vide letter dated
8th
May 2013. The firm was also asked to appear before the CLB in its next meeting if want to be
heard in person.
3. In response Mr. Faiz Rasool Chief Executive of the firm has submitted his reply in
which he has denied that the FID has contacted him and written him letters. He has further stated
as under:
a. That there are severe financial crises of the country and that there is no gas no
electricity no working environment, labor problems business migrations no more
investment on business to create jobs. So in this environment everyone is in problem;
to meet electricity bills, wages of employees, unsustainable low production volumes,
high costs of production and unaffordable circumstances and inevitable expenditures.
These are the major factors that we are unable to run the factory at full momentum
and capacity and at all levels. In our area light goes from 16-18 hours a day. So how
can we work? It is a multimillion investment at stake because of the bad conditions of
country.
b. That they have done big investment and are eager to bring up factory in full working
position otherwise will shift from Pakistan.
c. That country slams massive power load shedding and all chambers of commerce have
expressed serious concerns over the poor response of Government towards
unprecedented energy shortage of the industry.
d. That the Show Cause notice has been issued on one and first visit of FID and false
report of formal FID. I think they must be friendly with the companies rather to
indulge in wrong goings. They try to create easiness to industrials to create problems.
e. That I have done nothing wrong. There is no fault on my part and I am sent show
cause notice and not known to reason. I therefore request the competent authority to
look into the matter sympathetically and oblige.
3. The firm has been asked to appear before the Board for personal hearing in this meeting
and clarify their position on the subject matter.
Decision of CLB
The representative of the firm was called for personal hearing in the light of
previously served Show Cause Notice but no any representative attended the meeting, so
Board deferred the case for final opportunity of personal hearing.
27
Case No.6 Renewal of DML of M/s Katrina Pharmaceutical Industries (Pvt.) Ltd.,
Sheikhupura.
M/s Katrina Pharmaceutical Industries (Pvt) Ltd, Sheikhupura was inspected by a panel
of experts on 14.12.2007 for renewal of Drug Manufacturing License wherein panel did not
recommend renewal of license. Firm was served with the show cause notice and owner of the
firm was given personal hearing in 212th
meeting of the board held on 26.05.2008 and undertook
before the Board that he will suspend the production with immediate effect and will ready for
re-inspection after one month.
The CLB in its 212th
meeting decided to grant one month time for improvement of the
facility. The FID Lahore conducted inspections on 30.05.2008, 08.07.2008 and then on
15.06.2009 wherein he reported that at the time of inspection the entire manufacturing facility
was closed and no production activity was in progress. No technical person was present no
compliance of their undertaking regarding rectification and up-gradation was made by the firm
even after laps of a period of one year. The FID also recommend that the license of the firm may
be suspended as the firm has not done any compliance with reference to previous inspection
report and renewal of their DML was also not recommended by the Panel of inspectors. The
Board in its 218th
meeting held on 30-06-2009 decided to issue final show cause notice and call
the management for personal hearing before the next meeting of the Board. The firm was served
with show cause notice and advised to appear before CLB for personal hearing in person on
31-07-2009.
The firm applied for renewal of their DML for the period of 14-12-2009 to 13-12-2014 in time.
The panel was constituted on 25th
February 2011 but the inspection by the panel was not carried
out. However, Area FID and ADC Lahore conducted an inspection of the firm on 8th
February
2012 and reported that the whole of the plant was dismantled and the installation HVAC was in
process and the management informed that they are non-operational from the last three and half
years because the financial constraint. Area FID Lahore vide letter dated
28-11-2012 requested for reconstitution of the panel as new members of the CLB have been
nominated.
The Federal Inspector of Drugs, Lahore conducted the inspection of M/s Katrina Pharmaceutical
Industries (Pvt.) Ltd., Seikhupura on 04-03-2013 to check the status and GMP compliance of the
firm. The contents of inspection report of the FID are as under: -
a. That at the time of inspection the firm was closed and no production activity was in
process. Only two watchmen were there and one watchman Mr. Ata Ullah has given
the statement that the factory is closed for the past many months. It is also pertinent to
mention that Dr. Sheikh Akhtar Hussain, Federal Inspect of Drugs at that time, also
inspected the fm on 15.6.2009 and at that time the manufacturing facility was also
found closed. It was reported that no compliance of the firm’s undertaking regarding
rectification was made by the firm even after the lapse of one year. He recommended
that the license of M/s Katrina Pharma may be suspended as the firm has not done
any compliance and the renewal of their DML was also not recommended by the
panel
b. The firm was again inspected by Abdul Rashid Sheikh, Federal Inspector Drugs,
Lahore as the management has requested for deferment of inspections because of
their installation of HVAC system and other renovation and installation of HVAC
was in process. The management informed at that time that they are non-operational
from the last three and half years because of financial constraints.
28
c. Mr. Afzal Hameed, Chief Executive of the firm informed telephonically that HVAC
system has not been installed yet due to some payment problems.
d. The renewal of DML of the firm was not recommended, however another panel was
constituted but now the Board have been reconstituted under Drugs Regulatory
Authority of Pakistan, therefore, reconstitution of panel is required. The factory is
closed for the last five years; hence the matter may be submitted to Licensing Board
for further necessary action, please.
3. Keeping in view the above, show cause notice was issued to the firm vide letter dated 8th
November 2013. The firm was also asked to appear before the CLB in its next meeting if want to
be heard in person.
4. The firm has been asked to appear before the Board for personal hearing in this meeting
and clarify their position on the subject matter. Submitted for consideration of the Board in the
light of above background of the case as the renewal of DML of the firm is due last two periods.
Decision of CLB
The representative of the firm was called for personal hearing in the light of
previously served Show Cause Notice but no any representative attended the meeting.
Board after through discussion decided to suspend the manufacturing license under
Rule 8(14) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 till
rectification of shortcomings and verification thereof by panel. The Board further decided
to give another opportunity of hearing in the light of previous show cause notice.
Case No.7 Cancellation of Drug Manufacturing License No. (000663) (Formulation) of
M/s Al-Aju Cotton Industries Mir Pur Khas Sindh.
Federal Inspector of Drugs Dr. Najam-us-Saquib visited M/s Al-Aju Cotton
Industries on 28th June 2013 wherein the FID has reported that there was no production activity
underway and premises were found closed. He has further informed that letters and reminders to
the firms were issued but no reply from the firm was received. The neighboring person informed
that there is no production activity since long and this premises alongwith other surrounding land
has been purchased by another person namely Mr. Amjad Memon. On contact to Mr. Amjad
Memon he has confirmed that he has purchased the whole land and he does not know about
running a pharmaceutical unit, nor he is interested in the same. The FID has recommended for
cancellation of Drug Manufacturing License of M/s Al-Aju Cotton Industries, Mirpur Khas,
Sindh.
Decision of CLB
The Board in light of inspection report of area FID and after thorough discussion
and deliberations decided to issue Show Cause notice to M/s Al-Aju Cotton Industries,
Mirpur Khas, Sindh and called the firm for personal hearing in next meeting before
cancellation of DML. Board further decided to collect the DML and Inspection Book
through area FID.
29
Case No. 8 Renewal of DML unit - M/s Shazal’s Pharmaceuticals, Hattar.
M/s Shazal’s Pharmaceuticals, Hattar applied for renewal of their DML on 05-05-2011
The brief background of the case is as under: -
The application of renewal of DML of firm, being not on prescribed Form 1A is not
tenable and is liable to be rejected as provided under rule 5(2A) of the Drug (Licensing,
Registering and Advertising) Rules, 1976. The fact is that the firm did not submit their complete
renewal application and did not respond to DRAPs correspondence within thirty days as
admissible under above mentioned Rules. Further the management of the licensee/firm has also
been changed for which following is submitted for consideration of CLB to take decision in the
light of authority forwarded by Law Division as under.
2 The Law Division in the case of M/s Qamar Cotton Industries Okara wherein the
comments were solicited as whether the Drug Manufacturing License can be transferred to Legal
heirs of the company established under the sole proprietorship. The Law Division opined that the
license is a permissive right of an individual and could not be transferable to his son as
requested. As the license is neither transferable, assignable and heritable from the previous
owner/ seller to Rafi Ul Mulk (purchaser) as requested in receipt as the Drug Manufacturing
License. The new management may apply afresh for grant of Drug Manufacturing License under
the rules after surrender the DML by the previous owner/ licensee at present being sole
proprietor of the firm. Both the persons may be informed about the situation / status accordingly.
Decision of CLB
Board deferred the case for next meeting for want of complete back ground of the
case.
Case No.9 Renewal of Drug Manufacturing License of M/s Novartis Pharma Pakistan
Ltd, Karachi DML No. 000193 (Formulation)
Proceeding
Decision taken by Board is mentioned under the cases of Renewal of DML and Grant of
Additional Section of the said firm.
30
Case No.10 Application of M/s Abbott Laboratories Pakistan Ltd, Karachi for
Cancellation of their DML (No. 000005 Basic Manufacture).
Brief Background:
The Central Licensing Board in its 232nd
meeting discussed the case of M/s Abbott
Laboratories Pakistan Ltd, Karachi for cancellation of their DML (000005) Basic Manufacture.
After hearing the firm’s representative Mr. Anis Shah, Director Plant Operation, and
thorough discussion and deliberation among the members of the Board on the issue, the Central
Licensing Board did not accede to the request of the firm for cancellation of their DML No.
000005 (Basic Manufacture) being indigenous API manufacturing unit. The following
clarification from the firm and the Directorate of PE&R is awaited:
Documentary evidence supported by relevant documents / information mentioning that
why this license has not been feasible to operate.
The drugs registration directorate shall be asked for clarification regarding approval of
change of source of their Aluminum Hydroxide Gel for use in their registered products
(i.e. Antacids like Dijex MP and Dijex).
The firm shall be asked to clarify that how the import of Aluminum Hydroxide Gels had
been feasible in spite of enhanced duty structure where said API is approved for local
production under the rules?
The firm shall also be asked how their Formulation Products are being manufactured if
they have changed their source after closure of their facility?
Since, the representative of firm stated that they had been enhancing the capacity of this
plant from 500 kg to 1000 kg in the past and now how this plant is suddenly unfeasible to
run at once?
The Drug policy has given different incentives to basic / semi basic manufacture so the
firm’s request for cancellation of DML No. 000005 (basic manufacture) is absolutely
illogical / irrational that tantamount to deprive this country from an API, being
manufactured indigenously.
No clarification from the firm as well as from registration directorate received.
Decision of CLB
Board deferred the case till clarification/information by firm and Division of
Pharmaceutical Evaluation & Research of DRAP.
31
Case No.11 M/s The Searle Company Limited, Karachi DML No. (000016) Formulation
Manufacturing Nutraceutical Products.
The Central Licensing Board in its 232nd
meeting discussed the case of M/s The
Searle Company Karachi, regarding using of their premises for manufacture of Drugs. The Board
decided to get the facilities of M/s Searle Pakistan Limited, Karachi at Korangi site inspected by
a panel as this site is reportedly used for manufacturing nutraceutical products as informed by
Mr. Salim Isharat Chief Drug Inspector, Sindh (Member CLB). The Board further decided to get
the inspection of two separate premises of M/s Searle Pakistan Limited in Karachi i.e. Korangi
Industrial area and S.I.T.E Karachi by panel of experts to ascertain the status of licenses of these
Sites and check production activities being carried out at these two sites. In compliance a panel
was constituted who submitted its report as under:
i) The panel consisting of Syed Javed Yousaf Bukhar, Mr. Qaiser
Muhammad Chief Drug Inspector Sindh, Syed Hakim Masood, Area
FID, SITE, Karachi and Abdul Rasool Shaikh FID-III.
Summary of the report of un licensed unit of M/s The Searle Company situated at Plot
No.15/1, Sector 15, Korangi Industrial Area, Karachi.
The panel who inspected the premises informed that manufacturing of some food supplements
was underway. The panel further informed that their probiotics which are imported and repacked
here must be dealt under the uniform policy of the DRAP as probiotics are getting registrations
like Saccharomyces Bouldarii. The firm was advised to approach DRAP Authorities Islamabad
for clarification. The probiotics come under provision of Drugs Act, 1976 and registrations are
granted. The case relates to Quality Control and Registration Sections which may give their
inputs regarding non compliance / violations of Drug Act, 1976 and Rules framed there under
and may accordingly be treated under the ambit of Drug Act, 1976 and Rules framed there under.
Summary of the report of licensed unit of M/s The Searle Company situated at Plot No.F-
319, SITE, Karachi DML No.000016 (Formulation).
The panel as above inspected the license premises and observed that the firm is engaged in the
manufacturing of registered pharmaceutical products and the firm is still using packaging /
labeling components with old company name in few products as was witness during the
32
inspection. It is worth to mention that the name of the company has been changed with effect
from 29&30-07-2013
The panel advised the firm to voluntarily stop the packaging material bearing the name of
previous company and such finished products shall be hold for not to be sold till the approval of
CLB for utilization of the balance / remaining packaging inventories with old company name.
The Management assured the panel that they will get the approval from the Competent Authority
to utilize their remaining inventories of few packaging components. Under Schedule B(II) 6.3.4
states that out dated or obsolete primary packaging material or printed packaging material shall
be destroyed and its disposal be recorded. M/s Spencer Pharma Karachi was also not permitted to
use their old printed packaging material after the change of the name as Rules are very clear to
deal with such matters. The firm has violated the said provision of the Rules and a show cause
notice / warning as the Central Licensing Board deem appropriate may be issued and the hold
stock using old printed packaging material may be destroyed.
Decision of CLB
The Board in the light of panel inspection report of M/s. Searle Company, Plot No.15/1,
Sector-15, Korangi Industrial Area, Karachi decided to refer the case for further necessary
action to Division of Health and OTC Products (non-drugs) which deals the matters of
Probiotics as the said firm is involved in the manufacturing of probiotics.
Whereas, the Board in the light of panel inspection report of M/s. Searle Company, Plot
No.F-319, SITE, Karachi (DML No.000016-Formulation) decided to destroy the available
packaging /labeling components bearing old company name (The Searle Pakistan Ltd.,)
under Schedule-B(II)6.3.4 in the presence of panel. A show cause notice and personal
hearing on violation of conditions of Drug Manufacturing License shall be issued to the
firm and case shall be presented before CLB in its next meeting.
Case No.12 M/s Brand Pharma International, Karachi. DML No. 000684 (Formulation) -
(Case of Non-Compliance of Conditions of DML/cGMP)
The case of M/s Brand Parma International, Karachi was discussed in 232nd
meeting of
CLB and following decisions were taken.
i). The Board unanimously decided to suspend the DML No. 000684(Formulation) of
the firm for a period of six months, as the firm had contravened the conditions of DML
No. 000684 (Formulation) and due to non-compliance of cGMP under Schedule B of
Drugs (L, R & A) Rules 1976 and failed to appear before the Board in spite of five show
cause notices / opportunities of personal hearing given to the firm.
ii). The Board further decided to get explanation from the panel for not submitting inspection
report in the matter as directed by the Board vide DRAP letter dated 20-05-2013. It was
further decided to get the facility inspected by some other panel for facts finding and
present the report in the next meeting of the Board.
33
2. In compliance of the decision of the Board the panel comprising of Dr. Saifu-ur-
Rehman Khatak Director, CDL, Karachi. Dr. Najm-us-Saqib Area FID, DRAP, Karachi and
Mrs. Ume-e-Lela Area ADC, DRAP, Karachi reiterated their stance and forwarded the report
dated 05-11-2013 in response to DRAP’s letter dated 02-09-2013 the conclusion of which is
reproduced as under:
“based on observations made during the visit, it is evident that the firm is closed for any
production and QC activity at present”.
3. Further, a legal notice from Mr. Javed Ahmad Chhatari, (claiming to be the Advocate
Supreme Court of Pakistan) is received, wherein he has intimated that M/s Brand Pharma
International, Karachi bearing DML No. 000684 (Formulation) has been sold by Mr.
Muhammad Anees and all rights of proprietor ship has been sold out to
Mr. Rizwan Umer Shaikh S/o Manzoor Elahi Shaikh. He has further inform that from now
onward you are requested to address your correspondence to new proprietor i.e. Mr. Rizwan
Umer Shaikh S/o Manzoor Elahi Shaikh. The request of change of management cannot be
acceded to on following grounds.
i) The license is non transferable, non heritable and it is a permissive right issued to
the original owners, Directors, Partners etc.
ii) The firm was initially established between two partners and the licensing
Directorate neither received any request/statement regarding sale of their factory.
The Drug manufacturing License is the property of Government of Pakistan
(DRAP) and same should be surrendered by the selling party if so.
In case the DRAP receives the agreement of sale purchase deed accompanied by
all documents, dissolution / resolution of partners and surrendering of original
license bearing No.000684 to DRAP Authorities, the case for fresh grant may be
considered.
4. On the basis of above said ground the request of change of management cannot be
acceded to.
Decision of CLB
The Board keeping in view the facts of the case, unanimously decided to
extend suspension of DML for further period of six months and decided that the license is
non transferable, non heritable, assignable and it is a permissive right issued to the
original Owners, Directors, Partners etc.
The Board further decided that in case the DRAP receives agreement of
sale/purchase deed executed before the legal forum (Court of Law, Registrar of Firms &
SECP) accompanied by all legal documents, dissolution / resolution of partners and
surrendering of original DML bearing No.000684 to DRAP Authorities, the case for fresh
grant may be considered.
34
Case No.13 M/s Syntex Pharmaceuticals, Kamra Road, Attock City, DML No. 000290
(Formulation)
Background
The Central Licensing Board in its 232nd
meeting was apprised that the Federal Inspector
of Drugs along with Mr. Ahmad Mahmood Mumtaz, DDG (E&M) Islamabad visited M/s Syntex
Pharmaceuticals, Kamra Road, Attock City, DML (No. 000290) Formulation on 30-05-2013 to
check and verify the compliance of firm towards GMP and reported that the firm was found
closed for the time being and that the Management had informed further that they intend to open
the factory premises within a month. Thereby the firm had violated the condition of Drug
Manufacturing License under Drugs (Licensing, Registering & Advertising) Rules, 1976 and
taking into consideration the legal provisions as laid down under Section 41 of the Drugs Act,
1976 and the rules framed there under decided as follows: -
a. To issue a show cause notice to the firm as why the firm had been closed without
prior permission from or information to the Competent Authority and provide the
firm an opportunity of personal hearing in the upcoming meeting of the Board.
b. To get the unit inspected by a larger panel of experts to verify compliance of the
firm towards the conditions of DML and cGMP as required under the Drugs
(Licensing, Registering & Advertising) Rules, 1976 as reportedly by the FID, the
facility had been closed by the management at their own. The inspection report by
panel shall be placed before the Board in its next meeting for consideration /
decision.
c. The Board also desired to direct the FIDs / Field Officers to inspect such premises
in their respective area of jurisdiction for which he/she may take assistance of the
law enforcing agencies and that no stone should be left unturned to inspect such
units promptly even by follow up visits.
4. Now the management of M/s Syntex Pharma, Attock informs that their CEO has been
arrested in case of Ephedrine Quota. In absence of CEO how can firm improve further.
However they have trying to improve their facility to comply with GMP as has been
identified by Federal Inspector of Drugs.
Decision of CLB
Board deferred the case and decided to get a final report from area FID about the
present status of the firm.
Case No.14 M/s Everest Pharmaceuticals, Islamabad, DML No. 000535 (Formulation).
Brief Background
The Central Licensing Board in its 232nd
meeting and taking into consideration
the legal provisions as laid down under Section 41 of the Drugs Act, 1976 and the rules framed
there under was apprised that the Federal Inspector of Drugs, Islamabad-I had informed that he
visited M/s Everest Pharmaceuticals (Pvt) Ltd, Plot No.124, Industrial Triangle Kahuta Road,
Islamabad on 18-06-2013 for the purpose of GMP inspection. The firm was found closed and
that the security supervisor present at the gate informed him that the owner of the property has
got the possession of the building through learned Court Order. Thereby the firm had violated the
condition of DML.
35
2 The Central Licensing Board in its 232nd
meeting and taking into consideration
the legal provisions as laid down under Section 41 of the Drugs Act, 1976 and the rules framed
there under decided as follows
a. To issue a show cause notice to the firm as why the firm had been closed without prior
permission from or information to the Competent Authority and provide the firm an
opportunity of personal hearing in the upcoming meeting of the Board.
b. To get the unit inspected by a larger panel of experts to verify compliance of the firm
towards the conditions of DML and cGMP as required under the Drugs (L, R & A) Rules,
1976 as reportedly by the FID, the possession of the building / Licensed Premises has
been taken up by Owner of Property through some Court Order. The inspection report by
panel shall be placed before the Board in its next meeting for consideration / decision.
c. The Board also desired to direct the FIDs / Field Officers to inspect such premises in their
respective area of jurisdiction for which he/she may take assistance of the law enforcing
agencies and that no stone should be left unturned to inspect such units promptly even by
follow up visits.
3 The firm has now filed an Appeal before Civil Court Lahore, which is lying
pending before the Court and Federal Government has directed to plead the case and nominated
the defense counsel as well and case is subjudice as para wise comments have been submitted
before the Court.
Decision of CLB
Since the case is subjudice before the Honorable Civil Court, Lahore, hence the
Board did not take any decision.
Case No.15 Policy Regarding Establishment of Pharmaceutical Units Located in
Residential Areas.
Brief Back Ground
The Central Licensing Board in its 228th
meeting had decided to issue show cause notices
to the firms located in the residential area with the directions to shift their units to the industrial
areas. Accordingly as per directions of the Board show cause notices were served to the M/s
Bliss Industries Ltd, Karachi, M/s Cresent Cotton, Okara, M/s Soma Laboratories, Lahore and
M/s Shamsi Pharmacy, Lahore and opportunities of personal hearing had also been given to the
firms. The firms’ replies to the show cause notices were discussed in the previous meetings of
the Board. The cases were again discussed in 232nd
meeting held on 29th
& 30th
July 2013 of CLB
too in view of decisions taken in 231st meeting of CLB held on 31-01-2013.
The cases of the individual firms in detail and the decision of the Board taken thereof in
232nd
meeting are as under: -
S.# Name of Company / Case background Decision of CLB
1. M/s Bliss Industries Ltd, 225/2, J.M. Sadhu Naval
Rai Road, Karachi.
In response to show cause notice bearing No. F. 2-
15/95-Lic (Vol-I) dated July 2012. M/s Bliss
The Board in its 232nd
meeting
discussed the case in the light of
decision taken in 231st meeting of
the Board in detail. Syed Jawed
36
Pharmaceuticals had informed that they had started
construction of their facility at new site in Korangi
as per approved layout plan. But because of law and
order situation in Korangi Karachi they could not
completed their construction timely.
In compliance to the decision of CLB taken in its
231st
meeting a panel comprising Syed Jawed
Yousaf Bukhari, Member CLB, Area FID and Area
ADC was constituted to conduct the inspection of
the firm. Due to delay, a reminder was also issued
for timely conduction of inspection of the firm to
verify progress made by the firm at the new site so
far. In compliance to the decision of CLB taken in
its 231st meeting show cause notice/letter for
personal hearing dated 25th
July 2013, was issued
and the firm’s representative was called before the
Board. None of the accused/ representative of the
firm appeared before the Board for personal hearing.
Yousaf Bukhari member CLB
furnished a panel report which was
asked to inspect the new site of the
firm in Korangi Industrial area.
The Board was apprised by him
that Panel tried to contact Mr.
Ashraf, representative / spokesman
of the firm so that the new site may
be inspected to check the progress
but the management was not
serious and that he did not
coordinate and respond for the
needful. It was also disclosed by
the worthy member that the panel
also tried to trace out the location
of the new site in Korangi
Industrial area, but failed to find
out the same.
The Board in the light of above
said report of the panel and
decision taken in 231st meeting of
the CLB decided that
(i) To defer the case of firm
located in the congested
residential area of Karachi.
(ii) One more but the last
opportunity of personal hearing
be given to the owner /
management of the firm.
(iii) Failing to appear before the
CLB, the license of the firm shall
be suspended/ cancelled and case
shall be forwarded to Registration
Board for cancellation / suspension
of products registered in the name
of firm.
IV) Accordingly firm is called for
personal hearing before
cancelling/suspending DML.
Decision of CLB.
Mr. Raja Awais Mehmood
Janjua Advocate with power of
attorney given by M/s Bliss
Industries, Karachi appeared
and pleaded the case before the
Board.
The Board after hearing the case
37
at length and considering the
facts on record decided to
suspend the DML of M/s Bliss
Industries Ltd, 225/2, J.M.
Sadhu Naval Rai Road, Karachi
till the firm shifts its premises to
an industrial area. The Board
further decided to direct the
firm to strictly adhere to the
provisions of Schedule-B of
Drugs (LR&A) Rules, 1976.
2. M/s Cresent Cotton, Chowk Depalpur, Okara.
A show cause notice was issued to M/s
Cresent Cotton, Okara regarding their unit located in
residential area. In response to Show Cause notice
the firm has informed that it is located in
commercial / industrial area instead of residential
area and got NOC from TMA, Okara.
2. The Board in its 230th
meeting decided to
direct the area FID to inspect the premises again and
take the necessary documents as the firm is claiming
for verification. The Board also directed to advise
the area FID to take and verify the NOC obtained
from TMA, Okara and approval from concerned
provincial Building Control Authorities (BCA).
3. Subsequently the Area FID reported that the
facility is located on Main Adda Road. In front of
the factory there is a shop of Fazal Broast, TV
repairing shop, a clinic, on left there are furniture
making shops, Qamar Cotton Industries is also on
same road, and beside the industry one house has
been built above the shops. The firm has also
produced an attested copy (verified) of a letter of
Tehseel Officer TMA Okara certifying that Cresent
Cotton Industry situated at Chowk Depalpur Road is
a commercial / industrial area.
1. The FID in her report concluded that the firm is
located in commercial area.
2. Tehseel Officer (P&C), TMA Okara was also
requested vide letter No. F. 1-7/84-Lic (Vol-I)
dated 20-05-2013 for verification of a separate
Industrial Area in Tehseel Okara but the reply is
still awaited.
The Board was apprised about the provisions of
Schedule “B” of Drugs (Licensing, Registering &
The Board after thorough
discussion / deliberation,
considering the report of the FID
and keeping in view the legal
provisions decided as under: -
i). The case should be processed
and actions shall be taken as per
provisions of Schedule B of Drug
(L, R & A) Rules 1976.
ii). Management of the firm be
asked to shift to some Industrial
area as there is no provision of
Law &Rules that allows Pharma
unit in industrial/ commercial
area, as per current status of the
firm.
iii). Renewal of DML of the firm
will be decided in the light of
commitment of firm for shifting of
their unit to some industrial area as
per requirement of Law & Rules.
The firm was issued DML in
1978, now, the TMA Okara as
requested vide letter No. F. 1-7/84-
Lic (Vol-I) dated 20-05-2013 for
verification of a separate Industrial
Area in Tehseel Okara. The TMA,
Okara has provided a letter issued
by office of TMA, Okara in which
the TMA, Okara has informed that
the firm is located in commercial/
industrial area as there is no
declared industrial in Okara.
38
Advertising) Rules, 1976.
The case was placed before the Board for its
consideration/ decision, keeping in view various
industrial incidents/disasters which coasted loss of
precious human lives as in case of unfortunate
incident of M/s Orient Labs, Lahore.
Decision.
The Board decided to get
verified the above letter issued
by Tehsil Officer, TMA Okara
through area Federal Inspector
of Drugs. The report shall be
submitted before the Board for
consideration in its next meeting.
3. M/s Soma Laboratories 692-N, Samanabad,
Lahore.
A show cause notice was issued to M/s Soma
Laboratories, Lahore regarding their unit located in
residential area. In response to Show Cause Notice
the firm stated that they are not contravening the
section 41 of Drugs Act, 1976 because they got
license in 1981 while the rules for condition of
location of manufacturing was added in the year
1998. The firm was called for personal hearing in
230th
meeting of CLB but they did not appear before
the Central Licensing Board. The Board took serious
notice regarding manufacturing of drugs in
residential area and decided to defer the case till
next meeting and one more opportunity for personal
hearing was granted.
Mr. Mian Ghulam Jelani appeared for personal
hearing meeting of the Central Licensing Board in
its 231st held on 30-01-2013 and committed that they
will shift their unit within one year and has
voluntarily stopped the production. The Board
decided to suspend the production for a period of
three months and verification from Area FID was
also advised.
The area FID has submitted report dated 03-06-2013
stating that the firm was closed and no production
activities was observed.
The case was placed before the Board for its
consideration/ decision, keeping in view various
industrial incidents / disasters which coasted loss of
precious human lives as in case of unfortunate
incident of M/s Orient Labs, Lahore.
The Board after thorough
discussion / deliberations, taking
into account commitment of the
firm before the CLB in its previous
meeting and keeping in view the
legal provisions decided as under:
-
(i). Suspension of DML of the
firm with immediate effect for a
period of six months so as to
avoid any industrial incident /
disaster which may cost loss of
precious human lives as occurred
in case of M/s Orient Labs Lahore
as the firm is located in congested
residential area of Samanabad
Lahore. The area FID should
ensure the closure of unit /
stoppage of production and report
in this regard be submitted to CLB
on monthly basis without fail.
ii).The Drug Registration Board is
informed about the suspension of
DML of the firm for further
necessary action.
iii). The management be directed
to shift their unit in industrial area
and to furnish the progress report
regarding the shifting of unit as per
their commitment made before the
CLB in its 231st meeting held on
30-01-2013.
iv). Area FID be directed to
inspect the new site and submit its
progress report. The report of Area
FID is awaited.
39
Decision of CLB.
The Board after considering the
facts on record decided as under: -
The CLB upheld its previous
decision of 232nd
meeting and
extended the Suspension of
DML of the firm for further
period of six months.
Area FID be directed to
inspect the new site and
submit its progress report
which is long awaited.
The Board further directed to
issue a letter to Area FID and
Provincial Govts to verify the
availability of stocks of drugs
manufactured by firm in
market and furnish report.
The case is deferred till next
meeting of the Board.
4. M/s Shamsi Pharmacy, Samanabad, Lahore.
A show cause notice was issued to M/s
Shamsi Pharmacy, Lahore regarding their unit
located in residential area. In response to show cause
notice the firm has replied that they are not working
in old unit since 2010. Area FID as reported that the
firm has suspended its production and it is not
operational. They also want to postpone the matter
because of their father death and some family issues.
2 The firm was called for personal hearing in
230th
meeting of CLB but they did not appear before
the Central Licensing Board. The Board took serious
notice regarding manufacturing of drugs in
residential area and decided to defer the case till
next meeting and one more opportunity for personal
hearing was granted.
3. Mr. Faisal Maqbool the Son of deceased
owner appeared before the Board in 231st meeting of
CLB who committed that they are ready for
inspection at new place. The Board in 231st meeting
decided to get the inspection of the premises where
firm intends to shift their unit and decided to
suspend the production at the congested area of
Samanabad. Lahore. The board further decided to
get an inspection conducted by Area FID so as to
verify the production activity at existing site.
4. The Area FID in response to DRAP letter
The Board after thorough
discussion / deliberation,
considering the report of the FID,
taking into account commitment of
the firm before the CLB in its
previous meeting and keeping in
view the legal provisions decided
as under: -
(i). Suspension of DML of the
firm with immediate effect for a
period of six months so as to
avoid any Industrial incident /
disaster which may cost loss of
precious human lives as occurred
in case of M/s Orient Labs Lahore
as the firm is located in congested
residential area of Samanabad
Lahore.
ii). The Drug Registration Board
be informed about the suspension
of DML of the firm for further
necessary action.
iii). The management be directed
to shift their unit in industrial area
and to furnish the progress report
regarding the shifting of unit as per
their commitment made before the
CLB in its 231st meeting held on
40
dated 17-05-2013 has reported that she has
inspected the facility to check the production status
of the firm 20-06-2013 in the presence of Mr. Faisal
Maqbool Son of deceased owner of the firm. It has
been further reported that no production activity was
going on at the time of inspection. However,
finished goods were stored in large quantities in two
rooms without any temperature control. Bundles of
fresh units cottons of different products were also
store bearing manufacturing date 2009 & 2010 etc.
The FID also took samples of two products i.e. Mag.
Sulphate B.P. Batch No. 43 Manufacturing date 06-
2011 and Kaolin Light Batch No. 30 Mfg. date 06-
2010 for test / analysis purpose. The FID has also
stated that as per availability of sample of Mag.
Sulphate bearing Manufacturing date 06-2011 and
expiry date use within 04 years clearly show that the
firm has manufacturing the products after 2010
which is contrary to the reply of firm about the
closure of the unit since 2010. FID has also
mentioned that the products of M/s Shamsi
Pharmacy are also available in the Market bearing
manufacturing dates 2009, 2010 and 2011 etc.
30-01-2013.
iv). Area FID be asked about the
action taken on availability of
products manufactured in the
period of closure of firm available
in the market. The report of FID is
awaited.
Decision of CLB.
The CLB upheld its previous
decision of 232nd
meeting and
extended the Suspension of
DML of the firm for further
period of six months.
The Area FID be directed to
inspect the new site and
submit its progress report.
The Board directed to issue a
letter to Area FID and
Provincial Govts to verify the
availability of stocks of drugs
manufactured by firm in
market and furnish report.
The case is deferred till next
meeting of the Board.
Case No.16 Renewal of DML of M/s Rex Pharmaceutical Pakistan, Karachi.
(DML No. 000536) by way of Formulation.
M/s Rex Pharmaceuticals Pakistan Ltd, Karachi had requested for renewal of their DML on 28th
March, 2009 for the period from 01-04-2009 to 31-03-2014.
Accordingly a panel comprising of following members was constituted on 23rd
May, 2009: -
1. Mr. M. Moti-ur-Rab, Member, CLB, Karachi.
2. Area, FID, DCA, Karachi.
3. Dr. Obaid Ali, Federal Government Analyst, CDL, Karachi.
Area FID on 27th
July, 2009 informed that he has visited the firm and found closed and locked.
FID directed the Director of firm for contact and coordination so that renewal inspection may be
carried out.
A show cause notice was served to firm on 24th
October, 2009 in response of above said letter of
FID. A personal hearing was served to firm on 2nd
November, 2009 to appear before CLB on 5th
November, 2009.
41
The case was discussed in 219th
meeting of the Board. It was decided to issue show cause notice
to the firm with the directions to appear before the Board in next meeting. Accordingly a show
cause notice was issued and management of the firm was asked to appear before the Board in
220th
meeting but the management failed to appear before the Board.
The Board discussed the case in detail and decided to suspend the manufacturing license of the
firm for a period of three months.
Accordingly, DML was suspended on 19th
December, 2009 for three months.
CLB in its 221st meeting held on 30
th December, 2009 further extended the suspension period for
three months; the same was informed to the firm on 18th
February, 2010.
Background of the Case from QA Section
M/s Rex Pharmaceuticals Pakistan Ltd, Karachi was inspected on 06.03.2013 by Mr. Abdul
Rasool Shaikh, FID Karachi with reference to see/verify the GMP compliance. During the
inspection the FID pointed out number of serious shortcomings and gross violations in all
sections. The FID reported that GMP situation was so critical and the firm cannot be allowed to
manufacture life saving drugs under very un-hygienic conditions, without proper quality control
department including microbiological lab and lack of necessary technical and quality staff. The
FID directed the firm to suspend all kind of production activities initially for 15 days due to
severe non-GMP compliance.
Action Taken by DRAP:- Accordingly, a show cause notice was issued to the firm on
23.04.2013 along with the direction to stop production in all sections with immediate effect.
Reply of the firm:- In response of the show cause notice, the firm had submitted that they have
worked out on areas of development in compliance to GMP guidelines as advised by the FID in
previous inspection and also requested to withdraw the show cause and allow them to continue
their production activities. On the request of firm, the Vice Chairman, CLB had constituted
following panel to re-inspect the firm for verifying the improvement made by the firm and also
to see GMP compliance along with recommendation whether the renewal of DML may be
granted or not:
i) Dr. Muhammad Tanweer Alam, DDG (E&M) Karachi
ii) Mr. Qaiser Muhammad, Director DTL, Sindh.
iii) Mr. Saleem Isharat, Chief Drug Inspector, Sindh
iv) Mr. Abdul Rasool Shaikh, Area FID Karachi.
The case was placed before the Central Licensing Board in its 232nd
meeting where the firm was
also provided personal hearing. After considering all the aspects of the case, the Board had made
following decision which was also conveyed to the firm accordingly:-
i) The Board decided that the production will remain stopped till the
final approval for resumption of production by the Central
Licensing Board.
ii) The case was deferred by Central Licensing Board till its next
meeting as per request of the firm and also to fulfill legal
requirement w.r.t show cause notice and personal hearing.
42
Present Position: Later on, a aforesaid panel inspection report has been received which was
conducted on 04.07.2013 wherein the panel observed major GMP violations and reported that
the firm is not in a position to recommended the renewal of DML. The panel further
recommended that the firm may be given more time to rectify all the major shortcomings for
better compliance till that their production activities may be halted in larger public interest.
Decision of CLB
After thorough discussion and deliberations, considering the back ground of the
case and facts on record, Board unanimously decided to suspend the DML of the firm for a
period of three months under Rule 13 of Drugs (Licensing, Registering and Advertising)
Rules, 1976. The Board further decided to issue show cause notice and personal hearing to
the firm.
======== End ========
43
B. QUALITY CONTROL
ITEM I: CONFIRMATION OF THE MINUTES OF 232nd
MEETING.
The Board confirmed the Minutes without any change.
ITEM II: CASES DEFERRED IN 232nd
MEETING
S
N
o
Title of Firm/
Medical Store &
Accused Name
Offence Brief
1 (i) M/s Surat Khan
Medical Store,
Brewery Road, Opp
B.M.C Complex,
Quetta
(ii) Surat Khan,
Proprietor of M/s
Surat Khan Medical
Store, Brewery Road,
Opp B.M.C Complex,
Quetta.
(iii) Muhammad
Aslam Shah, Qualified
Person of M/s Surat
Khan Medical Store,
Brewery Road, Opp
B.M.C Complex,
Quetta.
(iv) Snaullah, (person
present at the time of
visit at M/s Surat
Khan Medical Store,)
(v) M/s Medicine
Point, Jinnah Road,
Quetta
(vi) Arshad Mehmood
S/O Sultan Mehmood
of M/s Medicine
Point, Jinnah Road,
Quetta.
(vii) Mehmood
Hassan. Qualified
Person of M/s
Medicine Point,
Jinnah Road, Quetta.
(F. No. 3-37/2010-
DDC (QC-I)
Manufacture /
Sale of
Spurious,
Drugs
Section
23(1)(a)(i),
23(1)(a)(x),
23(1)(c) of
Drug Act,
1976,
i. The Board was apprised facts of the case as
under:-
Samples of Amoxi-Clave, Batch No AE5475,
claimed to be manufactured by M/s Sandoz
GmbH Austria, (marketed by Sandoz Division,
Novartis Pharma Karachi), drawn from M/s
Surat Khan Medical Store, Brewery Road,
Quetta, by FID Quetta, on 18-06-2010 were
declared Spurious by F.G Analyst vide Test
Report No.R-646/2010, dated 08-07-2010. M/s
Surat Khan Medical Store, could not provide
the valid warranties/ bill in respect of the drug
FIR No. 14/2010 dated 06-07-2010 was lodged
against accused persons with FIA, Crime
Circle, Quetta, with the permission of
Chairman Central Licensing Board. The FIA in
its Challan has nominated Surat Khan,
Muhammad Aslam Shah, Snaullah, Arshad
Mehmood as accused in its Challan. The FID
later also included name of Mehmood Hassan
(Qualified person of Medicine Point) in list of
accused and requested permission for lodging
prosecution against all the accused.
Show cause notices were issued to accused on
09-05-2013 and they were called for personal
hearing before the Board on 29-07-2013 (232nd
meeting) but none of the accused appeared
before the Board. However, a person namely
Asadullah, claimed to be brother of one of the
accused Snaullah, appeared before the Board
and informed that the Surat Khan Medical Store
has already furnished warranty of the Medicine
Point in respect of the drug in question to FID
Quetta. He further stated that the accused
Snaullah could not come for personal hearing
because of the hearing of the case in Drug
Court on 30th
July, 2013. Since Asadullah failed
to produce any document / identity in support
of his claimed of being representative of the
accused Snaullah, so the Board was doubtful
about authenticity of his statement and
therefore decided to give final opportunity of
44
personal hearing to the accused in its next
meeting and accordingly defer the case.
ii. The accused were again called for personal
hearing in the current meeting but no one appeared
on behalf of any of the accused nor any intimation
was received with regards to their stance.
Decision:
iii. The Board after thorough consideration of the
available record/ facts of the case, including the
Challan furnished by FIA, decided to allow FID
Quetta to prosecute all the accused of the firm viz
M/s Surat Khan Medical Store, Brewery Road, Opp
B.M.C Complex, Quetta, Surat Khan, Proprietor of
M/s Surat Khan Medical Store, Muhammad Aslam
Shah, Qualified Person of M/s Surat Khan Medical
Store, Snaullah, (person present at the time of visit
at M/s Surat Khan Medical Store, M/s Medicine
Point, Jinnah Road, Quetta, Arshad Mehmood S/O
Sultan Mehmood of M/s Medicine Point, Jinnah
Road, Quetta. Mehmood Hassan. Qualified Person
of M/s Medicine Point, Jinnah Road, Quetta in Drug
Court Quetta for violation of Section 23(1)(a)(i),
23(1)(a)(x), 23(1)(c) of Drug Act, 1976.
Case No. 2 Manufacturing of Drugs without valid Drug Manufacturing License by M/s
Alfalah Pharma (Pvt) Ltd, Sheikhupura Road, Lahore. (F. No. 3-03/2012-
QC)
During proceedings of the case, the Board was informed about background of the case
as under:-
i. In January, 2012, when the initial reports of deaths / serious reactions in patients taking
medicine from Punjab Institute of Cardiology (PIC), Lahore were received, the FID
Lahore drew samples of Alfagrel Tablets 75mg, Batch No.034, from premises of M/s
Alfalah Pharmaceuticals Ltd., Lahore on 13-01-2012, for being one of the suspected drug
and also an FIR was lodged against the firm on 23rd
January, 2011 with allegations that
the firm had purchased raw material from open market in violation of Drug (Import &
Export) Rules 1976.
ii. Later the FID sealed the firm on 25-01-2012 on finding that it was operating without valid
Drug Manufacturing License at that time. The aforementioned sample of Alfagrel Tablets
was also declared substandard by Federal Government Analyst, Central Drug Laboratory
Karachi, on the basis of description. The firm, in response to FID’s letter, calling for
explanation, requested Appellate Testing of the sample under Section 22(4) of Drugs Act,
1976. However, since at that time the subject of “Drugs and Medicine” was devolved to
the provinces under 18th
Constitutional Amendment so, the FID handed over the case
along with case property to the Provincial Health Authorities, Punjab. The Provincial
Quality Control Board, Punjab later referred back the case to FID, Lahore, pointing out
various lacunas and the fact that DRAP had become functional and therefore competent to
consider the matter. The FID Lahore, while reporting the aforementioned case also
forwarded an incomplete Challan (No 07/2012), furnished by FIA, wherein it is stated that
the investigation is yet to be completed.
45
iii. Though, subsequently, it was learned that the drug Alfagrel Tablet of M/s Alfalah Pharma
Lahore, may not be associated with the death incidences relating to PIC, however, from
perusal of record, it appears that the firm have indulged in illegal manufacturing of
substandard drugs without valid Drug Manufacturing License. The Board was further
informed that subsequently the Drug Manufacturing License of was re-granted in 230th
meeting of CLB held on 31-08-2012.
iv. The Central Licensing Board in its 231st meeting held on 30-01-2013, while considering
the case, inter alia, decided to issue Show Cause notice to the firm. Accordingly show
cause notice dated 19th
February 2013, was issued and the firm’s representative was called
for personal hearing before the Board in its 232nd
meeting held on 29-07-2013. Since non
of the accused/ representative of the firm appeared before the Board in the aforesaid
meeting so the Board defered the case till next meeting in order to provide final
opportunity of personal hearing to the accused / firm.
2. Mr. Faisal Riaz, claimed to be nephew of the owner Mr. Muhammad Waseem
Chaudhry, submitted a written reply to the Board on behalf of the later wherein he has shown
his inability to appear before the Board for being out of country (in Canada). Mr. Muhammad
Waseem Chaudhry in his written statement stated that the production in their previously /
presently licensed premises was done mistakenly which may kindly be regularized since the
Drug Manufacturing license was re-granted to M/s Alfalah Pharma.
3. The Board thoroughly scrutinized and discussed record of the case and noted following
facts:-
i. The Provincial Quality Control Punjab while referring black the case to DRAP vide its
order dated 26-05-2012, inter alia, pointed out following legal flaws and lacunas in the
case:
a) Registration of FIR was granted without permission from the concerned
Board.
b) Non-availability of complaint (Istagasa) written to the in-charge of the Police
Station by FID.
c) Incomplete challan submitted by the investigating officer of FIA.
d) Complete challan has yet to be submitted.
The Board was apprised that at the time of occurrence of the incidence the subject of
“Drugs and Medicine” was devolved to provinces under 18th
Constitutional
Amendment so the then Drug Control Administration was not in a position to take any
legal action as the relevant Boards i.e Central Licensing Board and Drug Registration
Board were non functional / non existent. Since the required permission of the Board
for lodging FIR could not be granted at that time for the obvious reason so the FID
was asked to hand over the case along with case property to the Provincial Health
Authorities, Punjab. The Board was further informed that the FIA authorities and FID
Lahore, during the same period, also made the request for ex post facto approval of the
FIR which also could not be processed for the reason mentioned above.
ii. The Challan furnished by the FIA is in-complete which clearly state that the investigation
yet to be completed. The Challan mentioned a statement of Mr. Muhammad Waseem
Chaudhry, Director of Alfalah Pharma according to which the Production and Quality
Control Managers are responsible for the substandard manufacturing but the name of these
persons were not mentioned as accused being challaned (column-3 of the Challan) for the
reason that the investigation in not yet complete.
46
iii. It was also noted that the concerned Federal inspector of Drugs forwarded the case
alongwith Challan without specifying the nature of contravention, provision of the law
being violated, name of accused / responsible persons, conclusion and recommendations.
Decision:-
The Board in view of the available record and facts of the case decided as under:-
i. The FID concerned may be advised to furnish a comprehensive case by clearly specifying
the contravention, name of accused / responsible person, conclusion and recommendations
at the earliest.
ii. The concerned FID may also pursue the matter with FIA authorities for getting complete
Challan at the earliest.
iii. Advise from Law & Justice Division may be sought on the issue of ex post facto approval
of the Central Licensing Board for the FIR lodged in this case.
Case No.3 REFERENCE FROM PROVINCIAL QUALITY CONTROL BOARD
SINDH FOR CANCELLATION / SUSPENSION OF LICENSE OF FIRMS
FOR BEING CONVICTED BY DRUG COURTS UNDER DRUGS ACT,
1976
Giving background of the case the Board was apprised that the Sindh High Court on 14-
10-2010, while hearing in Cr. Revision Applications No. 103/2010 to 107/2010 filed by Sindh
Government, directed the respondents that, for persons convicted under Drugs Act, 1976,
provision of law and rules framed their under, which requires cancellation and or suspension of
licenses, be to complied with. The Secretary, Provincial Quality Control Board (PQCB), Sindh
forwarded the cases of conviction of M/s Standard Drug Company, M/s Z-Jans and M/s Kamtax
by Drug Court Sindh for compliance of the aforementioned High Court’s orders. The matter
was placed before the Central Licensing Board in its 232nd
meeting held on 29-07-2013, where,
the then Chief Drug Inspector, Sindh Mr. Saleem Isharat, who was also the member of the
Central Licensing Board, apprised the Board that in cases where Drug Courts have awarded
lighter sentences to the accused, the PQCB, Sindh, on directions of Supreme Court, approached
the Sindh High Court, for enhancing these sentences. The case is at present pending with Sindh
High Court, and the Court, in its hearing dated 14-10-2010, gave the directions for cancellation
/ suspension of licenses of convicts. Since the complete detail of cases, including back ground
of the cases, test reports and other relevant documents, required for consideration of the matter
and taking decision there off, have not provided by the PQCB, Sindh, so the Board deferred the
case with directions to obtain complete details of all such cases from the PQCB, Sindh for
consideration of Central Licensing Board in the next meeting.
2. The Board was further informed that subsequently the case (Cr. Revision Applications
No. 103/2010 to 107/2010) was again fixed on 15-08-2013 in the Sindh High Court and the
Court was informed of the above position with clarification that the requisite information has
already been called from the PQCB Sindh, which on receipt, will be placed before the Central
Licensing Board for its consideration in accordance with Rule 12 of The Drugs (Licensing,
Registering and Advertising) Rules,1976, which require that the Board conduct an inquiry in to
the case and provide an opportunity to the Licensee, for being heard, before cancelling or
suspending License.
3. Briefing about current status of the case, the Board was informed that the PQCB, Sindh
was accordingly requested number of time for providing requisite information, however,
complete details were not provided so far. Recently the DDG (E&M) Karachi was asked
coordinate with the concerned provincial authorities for obtaining the desired information. The
DDG (E&M) Karachi in response obtained details of only one case of M/s Z Jans
47
Pharmaceuticals, while, for other cases, he was asked by the Secretary Provincial Quality
Control Board to get the details of the cases from Drug Court Karachi.
4. On the basis of the record provided by the PQCB so far, brief description of the cases
alongwith sentences awarded are given below.
A. M/s Standard Drug Co., Hyderabad
S.
No
Case No / Product Name
Brief Description Sentence Awarded
1. Case No. 61/2011, Counterfeit
and Misbranded Drug
Linobex-C Syrup, Batch No.
LC-062
Sample drawn by Drug
Inspector District Dadu
from Imran Medical
Store, Mehar. The
Government Analyst
declared the drug
counterfeit and
misbranded as colour
scheme and presentation
of outer packing
resembles Lederplex
Liquid of M/s Wyeth
Karachi. Complaint
launched for violation of
Section 23(1)(a)(ii),
23(1)(a)(iii), 23(1)(a)(x)
in Drug Court Sindh on
19-11-2011. The accused
pleaded guilty.
Sentence till rising of
the Court to Imtiaz
Ahmed, Managing
partner, Haider Zaidi,
Production Incharge,
and Miss Sabeen
Usman, QC in-charge.
Fine of Rs 30,000 to
Imtiaz Ahmed and
Haider Zaidi and Rs
25,000 to Sabeen
Usman. An other
accused Mukhtiar
Ahmed is absconding
2. Case No.62/2011 Counterfeit
Drug Linobex-C Syrup, Batch
No. LC-022 (Resemblance with
Lederplex liquid)
Sample drawn by Drug
Inspector District Dadu
from Hunanin Medical
Store, District Dadu. The
Government Analyst
intimated his inability to
carry out test / analysis.
The labeling of drug
resemble to that of
Lederplex Liquid of M/s
Wyeth Labs. Complaint
launched for violation of
Section 23(1)(a)(ii), and
23(1)(a)(x) in Drug Court
Sindh on 26-11-2011. The
accused pleaded guilty.
Sentence till rising of
the Court to Imtiaz
Ahmed, Managing
partner and Miss
Sabeen Usman, QC
in-charge.
Fine of Rs 30,000 to
Imtiaz Ahmed and Rs
25,000 to Sabeen
Usman.
Other accused
Shakeel Ahmed
Baloch and Mukhtiar
Ahmed are
absconding
3. Case No. 41/2007, Sub-
standard Glycodyl Exp Cough
Syrup Batch No. GL-033
Sample drawn by Drug
Inspector District Thatta
from .D.O Health, Thatta
on 24-03-2004.The
Government Analyst
declared the drug sub-
standard. After completing
Sentence till rising of
the Court to Abdul
Ghaffar, Managing
Director, and Miss
Sabeen Usman, QC
in-charge.
Fine of Rs 25,000 to
48
the legal formalities
complaint launched for
violation of Section
23(1)(a)(v), 23(1)(a)(x), in
Drug Court Sindh on 14-
04-2007. The accused
pleaded guilty.
Abdul Ghaffar and
Sabeen Usman. An
other accused Ghulam
Murtaza Sheikh is
absconding
4. Case No. 55/2011 Counterfeit
Drug Lenobex-C Syrup, Batch
No. LC-065 (Resemblance with
lederplex liquid)
Sample drawn by Drug
Inspector District Umer
Kot from E.D.O, Health.
The Government Analyst
declared the drug
counterfeit as colour
scheme and presentation of
outer packing resembles
Lederplex Liquid of M/s
Wyeth Karachi. After
completing the legal
formalities complaint
launched for violation of
Section 23(1)(i),
23(1)(a)(ii) and 23
(1)(a)(x), in Drug Court
Sindh on 10-08-2011. The
accused pleaded guilty.
Sentence till rising of
the Court to Imtiaz
Ahmed, Managing
partner, Haider Zaidi,
Production Inchage,
Fine of Rs 30,000 to
Imtiaz Ahmed and
Haider Zaidi
Other accused
Mukhtiar Ahmed and
Najum-us-Sehr are
absconding
5. Case No. 41/2011 Counterfeit
Drug Staiflic 5mg Tablet (Folic
Acid), Batch No. SF-107
Sample drawn by
Divisional Drug Inspector
Hyderabad from Standard
Drug Company,
Hyderabad. The
Government Analyst
declared the drug
counterfeit. After
completing the legal
formalities complaint
launched for violation of
Section 23(1)(a)(ii) and
23(1)(a)(x), in Drug Court
Sindh on 21-05-2011. The
accused pleaded guilty.
Sentence till rising of
the Court to Imtiaz
Ahmed, Managing
partner, Haider Zaidi
Production In-charge
and Najma Perveen
Q.C In-charge
Fine of Rs 30,000 to
all the above accused.
6. Case No. 32/2008, Sub-
standard Linobex-C Syrup,
Batch No. 002
Sample drawn by Drug
Inspector District
Hyderabad from Naeem
Medical Store Hyderabad,
on 29-09-2000. The
Government Analyst
declared the drug sub-
standard. After completing
the legal formalities
complaint launched for
violation of Section
Sentence till rising of
the Court and fine of
Rs 25,000 to Miss
Sabeen Usman, QC
in-charge.
An other accused
Anees Ahmed is
absconding
49
23(1)(a)(v), 23(1)(a)(x)
and 23(1)(i), in Drug Court
Sindh on 01-03-2008. The
accused Sabeen Usman
pleaded guilty.
7. Case No. 31/2008 sub-
standard Glycodyl
Expectorent Cough Syrup,
Batch No. RF 007
Sample drawn by Drug
Inspector, District
Hyderabad from Naeem
Medical Store Hyderabad,
on 29-09-2000. The
Government Analyst
declared the drug sub-
standard. After completing
the legal formalities
complaint launched for
violation of Section
23(1)(a)(v), 23(1)(a)(x)
and 23(1)(i), in Drug Court
Sindh on 01-03-2008. The
accused Sabeen Usman
pleaded guilty.
Sentence till rising of
the Court and fine of
Rs 25,000 to Miss
Sabeen Usman, QC
in-charge.
An other accused
Anees Ahmed is
absconding
B. M/s Z-Jans Pharmaceuticals Peshawar
S.No Case No / Product Name
Brief Description Sentence Awarded
Case No. 14/2012
Substandard Lofsin Tablets
Batch No. 435
Sample drawn by
Provincial Drug Inspector
Naushero Feroz, on 23-09-
2009, declared
substandard by Provincial
Government Analyst. The
Inspector, after
completing the legal
formalities, lodged
complaint in Drug Court
Sindh for violation of
Section
23(1)(a)(v),23(1)(i). on
01-01-2012. The accused
pleaded guilty
Sentence the three
accused Zahid Khan,
Muhammad Rafiq and
Ghulam Muhammad,
till rising of the Court
and fine of Rs 25,000
to each accused
C. M/s Kamtex Cotton Industries, Kamoke
Details not provided
5. With regards to issue of provision of the detail record of the substandard cases, the
Board observed that the Health Department, Government of Sindh, being custodian of record of
these cases is the appropriate forum for providing the record. The Board further requested the
chief Drug Inspector Sindh, who was representing Sindh Government in the Central Licensing
Board, to facilitate for provision of the details/record of these cases in consultation with
DDG(E&M) Karachi.
50
6. The Board also discussed at length the modalities to be adopted for implementation of
the aforementioned decision of Sindh High Court. It was noted that as per procedure outlined in
Drugs Act, 1976 and Rule framed there under, the Board has to conduct an inquiry in to the
case and provide an opportunity to the Licensee, for being heard, before canceling or
suspending License. During deliberation a number of question come under discussion which
includes;
i. Will it be legally valid that the Central Licensing Board, with out adopting the
procedure outlined in Drugs Act, 1976, cancel/suspend Drug Manufacturing
License of the firms by relying upon the inquiry conducted and the procedure
adopted by the Provincial Drug Inspectors and Quality Control Board in the
substandard cases.
ii. Since proceedings of the cases initiated by the Provincial Inspector have already
finalized by the Provincial Health authorities and Drug Court has given verdict
in these cases, so if the Board has to follow the procedure outlined in Drug Act,
1976, would it not amount to reopening of cases by initiating fresh inquiry,
issuance of fresh show cause notices, if required, and giving opportunity of
personal hearing to the firms by the Central Licensing Board etc.
iii. Since the Drug Court has already awarded sentences to the firm/accused after
finding them guilty of contravention of Drug Act, 1976, so whether the Board,
after considering merit of the case, will be in position to take an independent
decision which might not be in consistent with the decisions of Courts.
Decision
The Board after detail deliberation was of the view that a number of legal points need to
be clarified before proceeding for implementation of decision of Sindh High Court. The Board,
therefore, decided that the case may be referred to the Law & Justice Division for legal opinion
on how to implement directions of the Sindh High Court. In the mean time relevant authorities
of the Health Department Government of Sindh may be pursue for obtaining the relevant
detail/document of these cases.
ITEM III: NEW CASES
S
N
o
Title of Firm/ Medical Store &
Accused Name
Offence Brief
1 i). M/s Shahnawaz General
Store, Chand Market, Bazar
Shaheedan, Mardan
ii) Shahnawaz,
Owner M/s Shahnawaz General
Store,
Chand Market, Bazar
Shaheedan, Mardan
(F. No. 4-02/2013-QC)
Manufacture /
Sale of
Spurious,
Drugs Section
23 (1)(a)(i) of
Drug Act, 1976
i. The Board was apprised detail of the case
as under:-
On a complaint from M/s Bio Lab
Islamabad, the FID Peshawar alongwith
ADC Peshawar and FIA team raided the
premises of M/s Shahnawaz General
Store, Mardan on 27-02-2013, and
seized Lazma Cream, Batch No. 473,
purported to be manufactured by M/s
Bio Labs, Islamabad, on suspicion for
being spurious.
The Federal Government Analyst later
declared the Lazma Cream as spurious
vide test report No. 373/2013 dated 27-
03-2013 and M/s Bio Lab has also
disowned the product.
51
FIR No. 08/2013 was lodged against
Shahnawaz, the owner of Shahnawaz
General Store, with FIA, Crime Circle,
Peshawar. The Shahnawaz Medical
Store failed to provide any evidence in
support of its claim that it is not
manufacturing the product.
Complete Challan dated 01-08-2013,
furnished by the FIA, has nominated,
Shahnawaz, the owner of Shahnawa
General Store, as accused in the case.
The FID has requested permission for
prosecution of accused in Drug Court
Peshawar.
Show cause notice issued to accused and
the Medical Store on 02-10-2013 and
they are called for personal hearing.
ii. Mr. Asfandyar Umar, Advocate,
appeared before the Board and claimed
that Lazma Cream was purchased from
Qazi Enterprises, Mardan, but he failed to
provide any documentary evidence
(invoice/warranty) in support of his
claimed. He further denied involvement in
any of the illegal activity and also raised
questions of jurisdiction of FID and FIA in
this case.
Decision:
iii. The Board, in view of personal hearing
and thorough consideration of the available
record/ facts of the case, including the
Challan furnished by FIA, decided to allow
FID Peshawar to prosecute all the accused
viz M/s Shahnawaz General Store, Mardan
and Shahnawaz, the Owner M/s
Shahnawaz General Store, in Drug Court
Peshawar for violation of Section 23
(1)(a)(i) of Drug Act, 1976.
52
ITEM IV MISCELLANEOUS CASES
Case No.1 DEATHS INCIDENCES AT LAHORE AND GUJRANWALA AREA
ALLEGEDLY ASSOCIATED WITH CONSUMPTION OF COUGH
SYRUPS UTILIZING SUB-STANDARD DEXTROMETHORPHAN RAW
MATERIAL – RE-CONSTITUTION OF INVESTIGATION
COMMITTEE
Giving background of the case the Board was apprised that the recommendations of
PQCB, Punjab regarding the cases of manufacturing of cough syrups by M/s Reko Pharmacal
& Ethical Lab Lahore, by utilizing substandard Dextromethorphan raw material, was
considered by Central Licensing and Drug Registration Boards and following decisions were
taken:-
A. The Central Licensing Board in its 231st Meeting held on 30-01-2013 decided as
under:-
i. Import of any raw material / drug form M/s Konduskar India is banned forthwith.
ii. WHO Pakistan may be approached with the request to take up the matter with the
Indian authorities through WHO India.
iii. Suspension of License of Oral Liquid / Syrup Section of M/s Reko
Pharmaceuticals for one year or till completion of investigation and decision by
the competent forum, whichever is earlier.
iv. Suspension of License of Oral Liquid / Syrup Section of M/s Ethical Labs for one
year or till completion of investigation and decision by the competent forum,
whichever is earlier.
v. Recommendations to the Drug Registration Board for Cancellation of Registration
of Tyno SF Syrup of M/s Reko Pharmaceuticals and Dextromethorphan Cough
Syrup and Cocil Syrup of M/s Ethical Labs
vi. Detail panel GMP inspection of the M/s Reko Pharmaceuticals and M/s Ethical
Labs
The Board further decided to take up the matter again after completion of
investigation by the relevant quarters
B. The Drug Registration Board in its 237th
meeting held on 26-02-2013 took following
decisions:-
i. While endorsing the ban on import from M/s Konduskar India, the Board
recommended for also involving trade bodies and diplomatic channels for taking
up the matter with the Indian authorities.
ii. Ministry of Commerce may be approached with the recommendation that a
cautious approach made may be adopted for granting Most Favored Nation
(MFN) status to the India in view of the substandard imports.
iii. A committee with following composition is constituted to thoroughly investigate
the matter and submit its finding and recommendations to the Board on priority
basis.
a. Representative from DRAP
b. Representative from the Government of Punjab
c. Two Experts in Pharmaceutical Sciences
d. Any other co-optive member the committee may require
iv. Suspension of registration of Tyno SF Cough Syrup of M/s Reko Pharmacal till
completion of investigation and decision by the competent forum.
53
v. Suspension of registration of Dextromethorphan Cough Syrup and Cocil Syrup of
M/s Ethical Labs till completion of investigation and decision by the competent
forum.
2. In light of the above decisions, the CEO, DRAP vide letter dated 20-03-2013
constituted following Committee in order to investigate / study the tragic incidents allegedly
associated with consumption of cough syrups, manufactured by M/s Reko Pharmacal and
Ethical Pharma Lahore, by:-
i. Mr. Sultan Ghani, Former Director Health Canada
ii. Syed Shahid Nasir, Ex-Member, Central Licensing Board, Ministry of Health
iii. Prof. Dr. Mahmood Ahmed, Dean, Faculty of Pharmacy & Alternate Medicine,
Islamia University, Bahawalpur.
iv. Dr. Mohammad S Iqbal, Professor, Department of Chemistry, Forman Christian
College, Lahore
v. Dr. Riaz Bhatti, Head of Pharmacy, Jinnah Postgraduate Medical Graduate
Centre, Karachi
vi. Prof. Dr. Muhammad Sualeh, Head of Pharmacognosy, Federal Urdu University,
Karachi
vii. Dr. Iftikhar Jaffery, Sr. Director / Head of Technical Division, Pfizer, Pakistan
viii. Dr. Obaid Ali, DDC (Trg & Pharmacy Services) DRAP, Islamabad will be the
Secretary / Coordinator of the investigation team / committee
3. However, the Committee could not show any progress after laps of over 06 months.
The C.E.O, DRAP, therefore, in consultation with Chairmen, Central Licensing and Drug
Registration Boards and with approval of Secretary, NHRS&C, re-constituted the Committee
with the following composition:-
i. Syed Shahid Nasir,207-S, Phase–II, DHA, Lahore (Chairman)
ii. Prof. Dr. Mehmood Ahmed, Dean, Faculty of Pharmacy & Alternate Medicine,
Islamia University, Bahawalpur.
iii. Prof. Dr. Muhammad S. Iqbal, Professor, Department of Chemistry, Forman
Christian College, Lahore
Iv Dr. Saif-ur-Rehman Khattak,Director, CDL, Karachi
v. Prof. Dr. Muhammad Bashir, Ex-Dean, Faculty of Pharmacy, Punjab University,
Currently Dean, Faculty of Pharmacy,
University of Lahore.
vi. Dr. Sheikh Akhter Hussain, DDG (E&M), DRAP, Lahore (Coordinator /
Secretary Committee)
The main objective of the Committee is to investigate the matter thoroughly, taking in to
account all aspects of the issue including scientific, technical, legal etc, and submit its
findings with clear and candid recommendations within a period of two months positively for
the consideration / decision of DRAP and the Policy Board.
Decision
The Board noted and ratified the decision of reconstitution of Committee and further
directed that since two months has already been passed so the Committee be asked to
expedite the matter.
54
Case No. 2:- REQUEST OF M/S EFROZE CHEMICAL INDUSTRIES FOR
RETURN OF SEIZED RAW MATERIALS, PRODUCT SAMPLES
AND LOG BOOKS
Giving background of the case the Board was apprised that M/s Efroze has
requested to return the raw materials, product samples and log book seized on 01st
February, 2012 by FID Karachi, on the ground that only one batch No. J093 of Isotab 20
tablets was involved in allege contamination/adulteration with Pyrimethmine Moreover,
they have been allowed to manufacture specified tablets in the Tablet Section by the Drugs
Appellate Board. The brief of the case was submitted before the Board as under:-
i. In January, 2012 on receipt of reports of over hundred deaths / serious reaction in
large number of patients receiving medicines from the Punjab Institute of
Cardiology, and subsequently, on receipt of information that a foreign Laboratory
had reported contamination of antimalarial drug “Pyrimethamine” in samples of
Isotab tablets of M/s Efroze Chemical Industries, sent by the Punjab Government,
a Joint Investigation team of FIA and Drug Control Administration Karachi
inspected M/s Efroze Chemical Industries (Pvt) Ltd., Karachi on 01-02-2012.
Seizures were made and not to dispose off orders were passed for stocks of finish
drugs, raw materials, equipment, machinery, documents, etc. The Central
Licensing Board in its 228th
meeting held on 08-06-2012, gave the permission for
keeping the seized stocks/materials in safe custody, which includes 11 raw
materials, log book for samples, batch documents of Quality Control/ Assurance
department (600 pages).
ii. The Provincial Quality Control Board Punjab, in the mean time, also carried out
its own investigation and later, vide it’s ordered dated 01-02-2012, give
recommendations to the Federal Government for cancellation of Registration of
the Isotab Tablet and Drug Manufacturing License of M/s Efroze Chemical
Industries, Karachi.
iii. The recommendations of PQCB Punjab and the investigation carried out by area
Federal Inspector of Drugs was considered by Central Licensing Board in its 231st
meetings held on 30-01-2013 and the Board decided as under:-
a) The License of Tablet Section of M/s Efroze Chemical be suspended for
one year
b) Recommendation to the Registration Board for the cancellation of
registration of Isotab Tablet
c) FID Karachi be directed to launch prosecution against the
responsible person(s)/ Director(s) of the firm in Drug Court Karachi
The FID Karachi accordingly launched prosecution against M/s Efroze
Chemical Industry in Drug Court Karachi. The case is still pending before
the Drug Court.
2. The request of M/s Efroze Chemical Industries, for return of seized raw materials and
record, was referred to the FID Karachi for comments. The FID in response has stated that the
materials in question are the case property and therefore it cannot be returned to the firm.
Decision
The Board endorsed the view of the FID that the seized material, being property of the case
currently under trial in Drug Court Karachi, cannot be returned to the firm unless directed by the
Court.
55
C. QUALITY ASSURANCE
Cases of firms whose production was stopped due to non-compliance of cGMP and violations
of Drugs (Licensing, Registering and Advertising) Rules, 1976
S. No. Name of firm Page No.
(Old CASES)
1. M/s Oval Pharmaceuticals, Lahore 2
2. M/s Lawrence Pharma (Pvt) Ltd, Lahore 3-4
3. M/s N.B.S Pharma, Lahore 5
4. M/s Prime Laboratories (Pvt) Ltd, Lahore 6-7
5. M/s Aptcure (Pvt) Ltd, Lahore 8-9
6. M/s Dosaco Laboratories (Pvt) Ltd, Lahore 10-11
7. M/s British Pharma, Lahore 12-13
8. M/s Risma Laboratories, Karachi 14
9. M/s Rex Pharmaceuticals Pakistan, Karachi 15-16
10. M/s Avicenna Laboratories (Pvt) Ltd, Lahore 17-18
11. M/s Ardin Pharmaceuticals, Karachi 19
12. M/s Meredoa Company, Karachi 20
(New Cases)
13. M/s Munawar Pharma, Lahore 21-22
14. M/s Harmann Pharma, Lahore 23-24
15. M/s The Searle Company Ltd, Lahore 25-26
16. M/s Hirra Pharmaceutical Lab, Lahore 27
17. M/s Medicare Disposable Industries, Lahore 28
18. M/s Ahson Drug Company, Tandoadam 29
19. M/s Epoch Pharmaceuticals, Karachi 30-31
20. M/s Nawan Laboratories (Pvt) Ltd, Karachi 32-33
56
Item No. I
(Old Cases of Quality Assurance)
Case No.1: M/s Oval Pharmaceuticals, Lahore
M/s Oval Pharmaceuticals, Lahore was inspected on 27.02.2013 by Mr. Abdul Rashid Shaikh,
FID Lahore with reference to see/verify the GMP compliance of the firm. During the inspection,
the FID had pointed out number of shortcomings in all the sections particularly approval of
layout plan for new changes and approval of technical staff. The FID had concluded that the firm
may stop production till improvements and compliance of their shortcomings. The management
also agreed and gave the undertaking to stop their production till upgrading and redesigning their
unit. The management claimed that it would take approximately 12-15 weeks and the production
shall remain stopped. They will inform to the DRAP office for re-inspection. A show cause
notice was issued on 25.03.2013 to the firm along with the direction to stop production in all
sections with immediate effect. In response of the show cause notice, the firm had submitted that
they have rectified all the shortcomings pointed out by the FID in his inspection dated
27.02.2013.
The case was placed before the Central Licensing Board in its 232nd
meeting where the firm was
also provided personal hearing. The firm informed the Board that their inspection was conducted
on 17.06.2013 and submitted a copy of the report which was not complete to evaluate overall
GMP compliance. However the QA Section had not received that inspection report from the
concern FID. After considering all the aspects of the case, the Board had made the following
decisions which were also conveyed to the firm accordingly:-
i) The Board observed that the panel report dated 17.06.2013 was not
complete to evaluate overall GMP compliance and rectification of
shortcomings etc.
ii) The Board decided to defer the case and place the same in the next
meeting of the Central Licensing Board in the light of the detailed
report submitted by the panel.
After the CLB 232nd
meeting, the panel has submitted complete report of M/s Oval
Pharmaceutical, Lahore which is submitted for the appraisal of CLB. The inspection of M/s Oval
Pharmaceutical, Lahore was conducted on 17.06.2013 by a panel comprising Dr. Sheikh Akhter
Hussain, Director Pharmacy Services Lahore, Mr. Muazzam Ali Khan, Secretary PQCB Punjab,
Mr. Asim Rauf, DDG (E&M) Lahore, Mr. Abdul Rashid Shaikh, FID Lahore and Mr. Ihsan-ul-
Haq Athar, ADC Lahore to check/verify the rectification of the shortcomings pointed out in the
inspection dated 27.02.2013.
The panel observed that most of the shortcomings have been addressed by the firm and
recommended the resume the production activities.
57
Decision of CLB:
The case was placed before the Central Licensing Board for consideration/decision.
The Board after thorough discussion, keeping in view the facts on record &
considering the inspection report of the panel of experts constituted as per
decision of the Board taken in its 232nd
meeting, agreed to the
recommendations of the panel & allowed the resumption of production in all
sections of M/s Oval Pharmaceutical, Lahore.
Case No. 2:- M/s Lawrence Pharma (Pvt) Ltd, Lahore
Background of the Case:
The inspection of M/s Lawrance Pharma (Pvt) Ltd, Lahore was conducted on 11.03.2013 by
Mrs. Aisha Khalil, FID Lahore with reference to see and verifying the GMP compliance by the
firm. The FID had pointed out number of serious shortcomings and gross GMP violations in all
the sections. Accordingly, show cause notice was served by this Authority on 03.04.2013 to the
firm with the direction to stop production in all the sections. In the meanwhile, the firm
submitted compliance report that they have made improvements as per advice by the FID and
was ready for re-inspection. A panel comprising of Mr. Asim Ruaf, DDG (E&M), Lahore, Mr.
Muazzam Ali Khan, Secretary PQCB Punjab and Mrs. Aisha Khalil, FID Lahore inspected the
firm on 29.05.2013, and recommended to resume production in veterinary vial section and syrup
section. The case was placed before the Central Licensing Board in its 232nd
meeting held on 29-
30th
July, 2013 where the firm was also provided opportunity of personal hearing. After
considering all the aspects of the case, the Board had decided the following:
i) The Board on the recommendations of the panel allowed the
provisional resumption of production in veterinary vial (general)
section and syrup section only.
ii) The Board also decided to conduct the comprehensive inspection of
the entire facility on approved audit Performa as per Schedule B-II
of Drugs Act, 1976 for monitoring/evaluation of GMP compliance
and conditions by the larger panel within 30 days after resumption
of production.
iii) The Board decided to ask the firm to provide copies of approval of
technical staff by Licensing Section i.e. Production in charge and
QC In charge to QA Section.
Compliance of the Decision of the Board:-
The Central Licensing Board’s above mentioned decisions have already been communicated and
complied with.
Position Explained:
Another inspection was conducted dated 29.07.2013 by the same panel at its own for verifying
the ratification of the shortcomings pointed out in the previous inspection conducted on
29.05.2013. The panel has recommended that the firm may provisionally be allowed production
in human Injectable section. The panel of experts However, mentioned that as the building was
old hence continuous improvement was required for GMP compliance and Schedule B-II under
the Drugs (Licensing, Registering and Advertising) Rules, 1976. The panel also suggested that
58
the request of the firm for manufacturing steroidal products in general Injectable section till
completion of separate area may be placed before CLB. (The copy of said report is annexed with
agenda).
The letter for panel as per above decision No. (ii) of CLB was issued but the firm has requested
to withdraw that letter of inspection by claiming that there is no need of inspection as they have
inspected once by the FID and twice by the panels.
Proceedings:-
The representative of the company was for personal hearing in its 233rd
meeting of CLB held on
31.12.2013and the case was placed before the Central Licensing Board for consideration.
Mr. Muhammad Razzaque Asadi, General Manager and Mr. Tariq Javed, QC Manager were
appeared before the Board. The representatives of the company informed the Board that the
inspection of the firm was conducted dated 29.07.2013 by the panel for verifying the ratification
of the shortcomings pointed out in the previous inspection conducted by the panel on
29.05.2013.
The representatives further pleaded that the panel has already allowed provisional production in
the human Injectable section. The solution preparation room for steroidal manufacturing will be
completed very soon. The representatives are willing to comply the instructions of CLB in letter
and spirit in future. The representatives also pleaded before the CLB that the company has
already been inspected thrice by various panel and the Board had ordered a Board Based
inspection which according to the representative of compliance is unjustified.
Decision of CLB:
i). The Board after hearing the views of the Firm, taking in account the
deliberations by the board members & considering the inspection report of the
panel of experts constituted as per decision of the Board taken in its 232nd
meeting, agreed to the recommendations of the panel & allowed the resumption
of production in Human Injectable section of the firm.
ii). The Board did not allow further manufacturing of steroidal preparations in
General Human Injectable Section and directed the Firm to apply afresh to
Licensing Division for approval of lay out plan & dedicated facility for steroidal
section as required under Schedule–B of Drugs (LR&A) Rules 1976. Till such
time the production in steroidal section will remain suspended.
iii). The directorate of PE&R shall be informed accordingly.
59
Case No. 3:- M/s N.B.S Pharma, Lahore
Background of the case:
The inspection of M/s N.B.S Pharma, Lahore was conducted on 26.02.2013 by Mrs. Majida
Mujahid, FID Lahore with reference to see/verify the GMP compliance of the firm. The FID in
her report had pointed out number of serious shortcomings and gross GMP violations in all the
sections. Accordingly show cause notice was served on 26.03.2013 to the firm with the direction
to stop production. The firm had submitted compliance report that they have made
improvements and rectified all the shortcomings and now ready for re-inspection. The CEO,
DRAP had constituted a panel comprising DDG (E&M) Lahore, Chief Drug Inspector, Punjab/
Director DTL, Punjab or Secretary PQCB, Punjab and area Federal Inspector of Drugs Lahore,
to re-inspect the firm to check the GMP condition of the firm. However, the panel inspection
could not be carried out before 232nd
meeting of CLB held on 29-30th
July, 2013. The case was
placed before the Central Licensing Board in its 232nd
meeting where the firm was also provided
personal hearing. After considering all the aspects of the case, the Board decided the following
which was conveyed to the firm accordingly:-
i) The Central Licensing Board deferred the case till receipt of inspection
report.
ii) The production of the firm will remain stopped till the final decision by
Central Licensing Board.
The inspection of M/s N.B.S Pharma, Lahore conducted on 16.08.2013 by a panel comprising
Mr. Ayaz Ali Khan, Chief Drug Controller, Punjab, Mr. Nadeem Iqbal, Member CLB and Mrs.
Majida Mujahid, FID Lahore with reference to check/verify the improvements made by the firm
which were pointed out in previous inspection conducted on 26.02.2013. The panel report has
been received according to which the panel had recommended that the firm may resume the
production and also directed to comply cGMP strictly on regular basis. (The copy of report is
attached with the agenda)
The member of the panel conducted the inspection were not the same as nominated by the CEO,
DRAP. A clarification from DDG (E&M) Lahore has been asked in this regard. However, same
is awaited.
The case is placed before the Central Licensing Board for consideration.
60
Decision of CLB:
The Board after thorough discussion and keeping the facts on records has decided as follows:-
i) The Board after thorough deliberations, keeping in view the facts on
record & considering the inspection report of the panel of experts
constituted as per decision of the Board taken in its 232nd
meeting, agreed to
the recommendations of the panel & allowed the resumption of production
in all sections of M/s N.B.S Pharma, Lahore.
ii) The Board showed its displeasure on making deliberate changes in the
composition of the panel of experts as in instant case by the field offices at
their own without seeking prior approval/permission from the Competent
Authority constituted for conducting/undertaking inspections of the Firms
for specific functions e.g Grant/Renewal of DML, verification of GMP
compliance etc. The Board directed the field offices to avoid such practices
in future .The Board desired to convey the said observations to the field
offices for compliance.
Case No. 4. M/s Prime Laboratories (Pvt) Ltd, Lahore
Background of the case :
Inspection of M/s Prime Laboratories (Pvt) Ltd, Lahore was conducted on 06.03.2013 by Mrs. Aisha
Khalil, FID Lahore with reference to see/verify the GMP compliance of the firm. During the inspection,
the FID had pointed out number of critical and sereous shortcomings in all sections. The FID concluded
that the syrup section and in-process quarantine areas were sealed under Section 18(I) of the Drugs Act,
1976. The FID had directed the firm to stop production immediately and re-test all the raw materials as
the storage of these materials was done without proper storage requirements for the last two years.
Accordingly, a show cause notice was issued on 23.04.2013 to the firm along with the direction to stop
production in all sections with immediate effect. On the request of the firm, the Chairman, Central
Licensing Board/CEO DRAP had constituted a panel comprising DDG (E&M), Lahore, area FID and
Chief Drug Inspector, Punjab/Director DTL, Punjab or Secretary PQCB Punjab to conduct inspection of
the firm in order to confirm the improvements made by the firm. However, the inspection report was not
received before 232nd
meeting of CLB held on 29-30th July, 2013. The case was placed before the Central
Licensing Board in its 232nd
meeting wherein the firm was also provided opportunity of personal hearing.
After considering all the aspects of the case, the Board had decided the following which were conveyed to
the firm & PPMA/Pharma Bureau accordingly:-
i) The Board decided to defer the case and that production of the firm will remain stopped till
rectification of shortcomings verified by the panel.
ii) The Board desired that the decision shall be taken in light of report of panel which will be
presented in upcoming meeting of Central Licensing Board.
iii) Board also took extremely serious notice of the harsh, unethical and unprofessional attitude of
Sheikh Zubair Iqbal, Director of the firm towards the Board during its proceedings and decided to
issue warning to him to refrain from such attitude before the Board and be careful in future.
61
iv) The Board also directed the representatives of PPMA and Pharma Bureau to communicate, the
serious concern and displeasure of all the Board members regarding the un professional, un ethical
and harsh attitude of Sheikh Zubair Iqbal, Director of the firm, to all their member companies in
general and the firm under reference in particular under intimation to the Central Licensing Board.
Position Explained before the Board:
The inspection report of M/s Prime Laboratories (Pvt) Ltd, Lahore conducted on 23.07.2013 by the
following panel was made in QA Section for verifying the rectification of the shortcomings pointed out
by the FID in the previous inspection of the firm conducted on 06.03.2013.
i) Mr. Muazzam Ali Khan, PQCB Punjab,
ii) Mrs. Aisha Khalil, FID Lahore
iii) Mr. Ajmal Sohail Asif, FID Lahore
Recommendation of the panel:
The panel was of the view that the firm has done improvements in storage and manufacturing areas. The
panel recommended that the production in all sections except syrup section may be resumed. The
inspection of syrup section will be conducted after the firm submits compliance.
In the light of decision of 232nd
CLB taken in its meeting, a warning letter was issued to Sheikh Zubair,
Owner of the firm i.e. M/s Prime Laboratories (Pvt) Lahore. In response of said letter, the owner has
regretted and gave the reason of harsh wording mainly due to non-working of microphone.
Later on, the same panel comprising Mr. Muazzam Ali Khan, PQCB Punjab, Mrs. Aisha Khalil, FID
Lahore and Mr. Ajmal Sohail Asif, FID Lahore inspected the firm on 05.11.2013 to check/verify the
improvements made by the firm in oral liquid section w.r.t the observations pointed out by the panel in its
previous inspection dated 23.07.2013.
The panel has reported that the firm has made improvements in Oral Liquid Section and the production in
Oral Liquid Section may be resumed.
Decision of CLB:
The Board after thorough discussion and keeping the facts on records has decided as follows:
i) The Board after thorough discussion, keeping in view the facts on
record & considering the inspection report of the panel of experts
constituted as per decision of the Board taken in its 232nd
meeting,
agreed to the recommendations of the panel & allowed the resumption
of production in all sections of M/s Prime Laboratories (Pvt) Ltd,
Lahore.
ii) The Board showed its displeasure on making deliberate changes in the
composition of the panel and conducting inspections /subsequent
inspections of experts as in instant case by the field offices at their own
without seeking prior approval/permission from the Competent
Authority constituted for conducting/undertaking inspections of the
Firms for specific functions e.g Grant/Renewal of DML, verification of
GMP compliance etc. The Board directed the field offices to avoid such
practices in future .The Board desired to convey the said observations
to the field offices for compliance.
62
Case No. 5:- M/s Aptcure (Pvt) Ltd, Lahore
Background of the Case:-
M/s Aptcure (Pvt) Ltd, Lahore was served with the show cause notice dated 23.04.2013 with the
direction to stop production in all sections. On receiving compliance report from the company’s
management dated 15.09.2013 another inspection was organized by the CEO DRAP comprising
of
i) Deputy Director General (E&M) Lahore,
ii) Secretary PQCB
iii) Area FID Lahore.
The said panel conducted inspection of the company on 16.07.2013 before the reply of the
company, wherein, the panel reported that GMP compliance of the company was unsatisfactory.
The case was placed before the Central Licensing Board in its 232nd
meeting held on 29-30th
July, 2013; the Board deferred the case, as the report of the panel was not received in the Board’s
meeting. The Central Licensing Board however directed the Federal Inspector of Drugs to ensure
that the production of the company has been stopped and to keep decision of e production stop
upheld.
On the request of the firm, a second panel was constituted by the Chairman, Central Licensing
Board comprising of:
i) Mr. Ayaz Ali Khan, Member Central Licensing Board,
ii) DDG (E&M) Lahore,
iii) Mr. Ajmal Sohail Asif, Area FID Lahore
iv) Area ADC Lahore.
Present Position:
During this period Mr. Ajmal Sohail Asif, FID Lahore conducted an inspection on 30.09.2013
for verifying the status of the production. The FID observed that the company was doing active
production and operational in respect of manufacturing. The FID seized the documents and
BMRs of 5 batches of different products on Form 2 under clause (f) of sub-section (1) of Section
18 as an evidence of the production in violation to the decision and directions of the Central
Licensing Board made in its 232nd
meeting.
Another show cause notice to the firm has been issued on 12.11.2013 by this Authority with the
direction to stop production in all sections immediately. The firm in their reply submitted that
they have manufactured some batches and requested for apology on humanitarian ground. The
representative of the company was called for personal hearing and the case is placed before the
Central Licensing Board for consideration/decision, please.
Proceedings:-
Mr.Muhammad Masood, Chief Executive of the firm and Raja Muhammad Farooq Director
Marketing appeared before the Board for personal hearing. Mr.Muhammad Masood, Chief
Executive of the Firm tendered his apology before the Board on producing limited batches of
their different products for fulfilling the supply orders of hospitals during suspension period of
their DML as reported by area FID.
63
Decision of CLB:
i) The Board after considering the inspection report of the panel of experts
constituted by competent authority agreed to the recommendations of the
panel & allowed the resumption of production in all sections.
ii) The Board directed to issue a strong warning to firm for producing
limited batches of their different products for fulfilling the supply
orders of hospitals during suspension period of their DML as reported
by area FID and confessed by the Firm also.
iii) The board further directed that area FID will collect the details of
production of batches and firm is directed to recall the stocks for
destruction manufactured during suspension period from market and
hospital.
iv) The area FID will submit the compliance report so that a panel be
constituted for the destruction of the recalled batches manufactured
during suspension period from market and hospital.
Case No. 6:- M/s Dosaco Laboratories (Pvt) Ltd, Lahore
Background of the case:
GMP inspection of M/s Dosaco Laboratories (Pvt) Ltd, Lahore was conducted on 28.03.2013 by
Mrs. Aisha Khalil, FID Lahore verifying the compliance. During inspection the FID had pointed
out number of serious shortcomings in all sections. The FID had concluded that:
i) In view of very serious observations, the firm was directed to immediately stop
production in all the sections;
ii) The penicillin containing products should be de-registered as dedicated facility is not
available.
iii) The segregated area for steroidal products is also required.
iv) Sterile area for eye drops is also not available.
Accordingly, a show cause notice was issued on 29.04.2013 to the firm along with the direction
to stop production in all sections with immediate effect. In response of the show cause notice, the
firm had submitted that they have started the maintenance work as suggested by the FID and all
the pin pointed issues were being worked out. Due to electricity they were facing some delay. As
soon as they would rectify all the shortcomings and make improvements, they would inform to
this Authority for re-inspection.
The case was placed before the Central Licensing Board in its 232nd
meeting where the firm was
also provided personal hearing in which the firm had submitted an undertaking to the Board that
they would remove all the shortcomings pointed out by the FID in next 6 months and will
intimate the Central Licensing Board accordingly and the production will remain stopped. After
considering all the aspects of the case, the Board had made following decisions which were also
conveyed to the firm, Federal and Provincial Drug Inspectors,, Registration Section and
Licensing Section accordingly:-
64
i) The Board acceded to the request of the firm regarding extension in time period
for renovation/upgradation work for a period of 6 months. However, the
production of the firm will remain stopped till final decision of CLB.
ii) The Central Licensing Board also desired that instruction/information should be
issued/conveyed to all FIDs and all provincial Chief Drug Inspectors (Punjab,
KPK, Sindh, Baluchistan, Gilgit-Baltistan, ICT) regarding stoppage of production
of the firm w.e.f. 29.04.2013 with the advise to ensure that a market/institutional
survey should be conducted to check the availability of Drugs of M/s Dosaco
Laboratories (Pvt) Ltd, Lahore manufactured after 29.04.2013, and for any action
taken under the law/rules shall be presented before the Board.
iii) The Board further decided to ask the firm to get layout plan of the building
approved for eye drops, penicillin (dedicated) and steroidal products/drugs as
required under rules.
iv) The Registration Board/Directorate of Registration will also be appraised about
the decision of CLB regarding suspension of products/drugs i.e. eye drops,
penicillin and steroids containing products manufactured in these sections for
immediate action and compliance at their end as firm does not possess
manufacturing facilities/areas for these products as required under the rules.
During this period, Mrs. Aisha Khalil, FID Lahore inspected the firm on 04.09.2013 with
reference to check the status of the firm and focused on verification of stoppage of production as
per decision of Central Licensing Board dated 03.09.2012. The FID reported that the firm was
actively involved in production which is clear violation to decision and directions of the CLB
made in its 232nd
meeting.
Position Explained:
Another show cause notice to the firm has been issued on 12.11.2013 by this Authority with the
strict direction to stop production in all the sections immediately on violating the conditions of
License and Good Manufacturing Practice (GMP) as laid down under Drugs (Licensing,
Registering and Advertising) Rules, 1976 and had intentionally violated their own
commitment/undertaking and the directions of the Central Licensing Board.
Proceedings:-
Mr. Muhammad Azeem, Quality Control In charge and Mr. Humayun Rashid, Production In
charge of the firm appeared before the Board for personal hearing. They have stated that they
had reprocessed the small quantity of batch. They had not sold any batch in the market.
Decision of CLB:
The Board after considering the request of the representatives of the company and keeping the
basic ground of the inspections has decided the following:
i) The Board decided to suspend the production activities till the final approval
by CLB.
ii) The company be directed to provide the detail of production and recall the
stocks for destruction. The Area FID will submit its report.
iii) The area FID has to watch the destruction of the recalled products.
65
Case No. 7:- M/s British Pharma, Lahore
Inspection of M/s British Pharma, Lahore was conducted on 03.04.2013 by Mrs. Aisha Khalil, FID
Lahore for verifying the GMP compliance of the firm. During inspection, the FID had observed number
of serious GMP violations. The FID concluded that the firm did not rectify the shortcomings which were
pointed out in previous inspection even after the lapse of almost 10 months. At this juncture, company
voluntarily stopped their production activities. Accordingly, a show cause notice was issued to the firm on
09.05.2013 along with the direction to stop production in all sections with immediate effect. In response
of the show cause notice, the firm had submitted that they have completed all the renovation and up-
gradation work and requested to resume production activities and are ready for re-inspection.
The Chairman, Central Licensing Board/CEO DRAP had constituted a panel for re-inspection comprising
of the following members for confirming the improvements made by the firm.
i) DDG (E&M), Lahore, (Dr. Sheikh Akther Hussain)
ii) Chief Drug Inspector, Punjab/ Director DTL, Punjab or Secretary PQCB Punjab
(Mr. Ayyaz Ali Khan)
iii) Mrs. Aisha Khalil, Area FID Lahore
However, the inspection report was not received before 232nd
meeting of CLB held on 29-30th July, 2013.
The case was placed before the Central Licensing Board in its 232nd
meeting where the firm was also
provided personal hearing. After considering all the aspects of the case, the Board had decided:
“Deferred the case and decided that the production of the firm will remain
stopped till panel inspection and final decision by Central Licensing Board in
the light of panel inspection report”.
Later on, the inspection report of the firm conducted by the said panel on 22.07.2013 was received. The
panel again pointed out number of shortcomings which need improvements. The firm agreed with the
suggestions of panel.
The representative of the company was called for personal hearing and the case is placed before the
Central Licensing Board for consideration.
Proceedings:-
The representative of the company was for personal hearing in its 233rd
meeting of CLB held on
31.12.2013and the case was placed before the Central Licensing Board for consideration.
Mr. Muhammad Akram, Production In charge appeared before the Board wherein he has informed that
they have made all improvements as advised by the panel and will be ready for inspection at the mid of
January, as the electric transformer is under installation.
Decision of CLB:
The board decided to upheld the decision of 232nd
meeting of CLB that the production of the firm
will remain stopped till panel inspection and final decision by Central Licensing Board in the light
of panel inspection report.
The production of the firm will remain suspended till the approval by the CLB.
The firm will be directed to get approval of technical staff from DRAP.
66
Case No. 8:- M/s Risma Laboratories (Pvt) Ltd, Karachi
Background of the case:
The show cause notice to M/s Risma Laboratories (Pvt) Ltd, Karachi was served on 16.05.2013
with the direction to stop production in all sections. The company had informed on 25.05.2013
that they had made all the improvements and up-gradation work in all sections and are ready for
re-inspection. On the request of firm, the Chairman, CLB/CEO DRAP had constituted following
panel to re-inspect the firm for verifying the improvement made by the firm and also to see GMP
compliance.
i) Dr. Muhammad Tanweer Alam, DDG (E&M) Karachi
ii) Mr. Qaiser Muhammad, Chief Drugs Inspector, Sindh/Member
CLB
iii) Mrs. Muneeza Khan, Area FID Karachi.
The inspection of the firm had not been conducted till 232nd
meeting. The case was placed before
the Central Licensing Board in its 232nd
meeting where the firm was also provided personal
hearing. After considering all the aspects of the case, the Board had made following decision
which was also conveyed to the firm accordingly:-
The Board deferred the case and decided that production of the firm
will remain stopped till panel inspection and final decision by Central
Licensing Board in the light of panel inspection report.
Present Position:-
Later on, the panel inspection of the company was conducted on 04.11.2013 by the aforesaid
panel.
The panel was of the opinion to continue the action taken by the area FID for suspension of the
manufacturing operation till further orders by the Board concerned. The panel also passed “Not
to dispose off orders” for 149 drums/bags of expired raw material in the raw material store.
The representative of the company was called for personal hearing and the case is placed before
the Central Licensing Board for consideration.
Proceedings:-
The representative of the company was for personal hearing in its 233rd
meeting of CLB held on
31.12.2013and the case was placed before the Central Licensing Board for consideration.
Mr. Sohail Riaz, Director/GM of the firm appeared before the Board wherein he has requested
the Board to allow the production in the re-packing section.
67
Decision of CLB :
The Board after considering the views of the representatives of the company has decided the
following:
The Board suspended the manufacturing license (Formulation) in all areas for a period of
three months under Rule 13 of Drugs (Licensing, Registering and Advertising) Rules, 1976
for rectification of observations made during the inspection by the panel.
The Board also did not accede to the recommendations of panel for manufacturing of
External Preparations for export purpose in the light of rule 17(2) of Drugs (LR& A) Rules,
1976.
The Board further decided to issue Show Cause Notice and Personal Hearing in the next
meeting of CLB.
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Case No. 9:- M/s Rex Pharmaceutical Pakistan, Karachi
Background of the Case: M/s Rex Pharmaceuticals Pakistan Ltd, Karachi was inspected on
06.03.2013 by Mr. Abdul Rasool Shaikh, FID Karachi with reference to see/verify the GMP
compliance. During the inspection the FID pointed out number of serious shortcomings and
gross violations in all sections. The FID reported that GMP situation was so critical and the firm
cannot be allowed to manufacture life saving drugs under very un-hygienic conditions, without
proper quality control department including microbiological lab and lack of necessary technical
and quality staff. The FID directed the firm to suspend all kind of production activities initially
for 15 days due to severe non-GMP compliance.
Action Taken by DRAP:- Accordingly, a show cause notice was issued to the firm on
23.04.2013 along with the direction to stop production in all sections with immediate effect.
Reply of the firm:- In response of the show cause notice, the firm had submitted that they have
worked out on areas of development in compliance to GMP guidelines as advised by the FID in
previous inspection and also requested to withdraw the show cause and allow them to continue
their production activities. On the request of firm, the Vice Chairman, CLB had constituted
following panel to re-inspect the firm for verifying the improvement made by the firm and also
to see GMP compliance along with recommendation whether the renewal of DML may be
granted or not:
v) Dr. Muhammad Tanweer Alam, DDG (E&M) Karachi
vi) Mr. Qaiser Muhammad, Director DTL, Sindh.
vii) Mr. Saleem Isharat, Chief Drug Inspector, Sindh
viii) Mr. Abdul Rasool Shaikh, Area FID Karachi.
The case was placed before the Central Licensing Board in its 232nd
meeting where the firm was
also provided personal hearing. After considering all the aspects of the case, the Board had made
following decision which was also conveyed to the firm accordingly:-
iii) The Board decided that the production will remain stopped till the
final approval for resumption of production by the Central
Licensing Board.
iv) The case was deferred by Central Licensing Board till its next
meeting as per request of the firm and also to fulfill legal
requirement w.r.t show cause notice and personal hearing.
Position Explained:
Later on, a aforesaid panel inspection report has been received which was conducted on
04.07.2013 wherein the panel observed major GMP violations and reported that the firm was not
in a position to recommend the renewal of DML. The panel further recommended that the firm
may be given more time to rectify all the major shortcomings for better compliance till that their
production activities may be halted in larger public interest.
The representative of the company was called for personal hearing and the case was placed before the
Central Licensing Board in its 233rd
meeting held on 31.12.2013 for consideration.
69
Decision of CLB:-
After thorough discussion and deliberations, considering the back ground of the case
and facts on record, Board unanimously decided to suspend the DML of the firm for a period
of three months under Rule 13 of Drugs (Licensing, Registering and Advertising) Rules, 1976.
The Board further decided to issue show cause notice and personal hearing to the firm and
advised for market survey of products manufactured by firm.
70
Case No. 10:- M/s Avicenna Laboratories (Pvt) Ltd, Lahore
Background of the Case:
Inspection of M/s Avicenna Laboratories (Pvt) Ltd, Lahore was conducted on 04.03.2013 by
Mrs. Aisha Khalil, FID Lahore with reference to see/verify the GMP compliance of the firm.
During inspection, the FID had pointed out gross violations in all sections. The FID further
reported that the firm had registration of 10 injectable products including penicillin/steroids
whereas, the injectable section is not approved by the DRAP, Licensing Section but company
had been granted the registration of the same. Accordingly, a show cause notice was issued to the
firm on 26.04.2013 along with the direction to stop production in all sections with immediate
effect. In response, the firm submitted that they have completed all the renovation and up-
gradation work in their manufacturing area. The company had requested to resume production
activities, withdraw the show cause notice and ready for re-inspection. The case was placed
before the Central Licensing Board in its 232nd
meeting wherein the firm was also provided
personal hearing.
The Board after giving patient hearing and considering all the aspects had made the following
decisions which were conveyed to the firm accordingly:-
i) The Board took serious notice that without prior approval from or intimation
to Central Licensing Board (Licensing Section) how the firm involved in
renovation of vaccine production area for which the firm should be asked for
clarification by QA Section.
ii) The Board further decided to direct the firm to establish a self
contained/dedicated facility for production of Penicillin containing
products/drugs and no production activity of penicillin containing products
shall be conducted till provision of dedicated/self contained facility as per
requirement of relevant rules and same approval by the CLB.
iii) The Central Licensing Board decided that the production will remain stopped
till the final approval of Central Licensing Board.
iv) The Central Licensing Board also decided for a broad based inspection of
unit by a panel as per audit Performa devised as per Schedule B-II of Drugs
(Licensing, Registering and Advertising) Rules 1976 framed under Drugs Act,
1976 in order to check/verify the GMP compliance level of the firm.
Position Explained:
The firm did not submit the compliance report for doing needful on the decisions of the Central
Licensing Board despite issuance of reminder to the firm on 23.10.2013 in this regard.
The representative of the company has been called for personal hearing and the case is placed
before the Central Licensing Board for consideration.
Proceedings:-
The representative of the company was called for personal hearing and the case was placed before the
Central Licensing Board in its 233rd
meeting held on 31.12.2013 for consideration.
71
Mr. Muhammad Shafiq, Production Manager appeared before the Board and pleaded that they
are not going to manufacture Penicillin products and has improved the general GMP. The
representative has not provided any letter of withdrawal of Penicillin products at the time of
personal hearing.
Decision of CLB:-
The Board after listening to the representative of the company making thorough discussion and
keeping the facts on records has decided as follows:-
i) The Board decided that the production will remain suspended in all
sections till the compliance and good GMP report. Board constituted a
panel comprising of Mr. Mouzam Ali Khan, area FID and ADC to
inspect the firm. The Board delegated the power to its Chairman for
allowing resumption of production in case the panel recommends for
resumption of production.
ii) The production in the vaccine and penicillin sections will remain
suspended. If the company has made any structural changes, they have
to get permission from Licensing Section.
72
Case No. 11:- M/s Ardin Pharmaceuticals, Karachi
The brief of the case is that, the inspection of the firm M/s Ardin Pharmaceuticals, Karachi was
conducted on 08.03.2013 by Dr. Shahid Hussain, FID Karachi to check the GMP compliance.
The FID pointed out number of serious shortcomings in all sections. Accordingly, a show cause
notice was served by this Authority on 25.03.2013 with the direction to stop production. The
case was discussed in 232nd
meeting of Central Licensing Board held on 29-30th
July, 2013,
wherein, the Board after detailed discussion/deliberation decided as under:-
The CLB after hearing the views of the Director of the firm, acceded to the
request of the firm for extension in time period of three months to
upgrade/renovate their facility subject to the condition that the production
will not be resumed during up-gradation/renovation work and till decision
of the CLB after verification of rectification of shortcomings by the panel of
experts.
The firm will get the layout plan of their building/sections approved in case
of up-gradations/improvements of existing facility if any change or
alteration is made in the existing/approved layout. The case shall be
brought before the notice of Central Licensing Board. In case of failure to
rectify the shortcomings and no further time shall be granted and exparte
decision shall be taken by the CLB.
The firm had requested for grant of further three (3) months time for completing their renovation
work which is against the decision of the Board.
The case was placed before the Central Licensing Board for consideration.
Decision of CLB:-
The Board after thorough discussion and keeping the facts on records has decided as follows:-
i) The Board after considering the facts on record and taking the lenient view
decided that the company may be allowed one more month for improvement
and the directions of suspension of production will continue till the
re-inspection by the panel of experts.
ii) In case of no reply and after the laps of the grace period, a new show cause
notice will be issued for processing of case of cancellation of DML.
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Case No. 12:- M/s Meredoa Company, Karachi
M/s Meredoa Company, Karachi was inspected on 08.03.2013 by Dr. Shahid Hussain, FID
Karachi with reference to see/verify the GMP compliance of the firm. During the inspection, the
FID had pointed out number of serious shortcomings in all sections. The FID directed the firm to
stop production immediately and also recommended to cancel the drug manufacturing license of
the firm in larger interest of the public. Accordingly, a show cause notice was issued to the firm
on 23.04.2013 along with the direction to stop production in all sections with immediate effect.
The case was placed before the Central Licensing Board in its 232nd
meeting; the company was
provided personal hearing. The owner of the firm informed that he was intending to perform
Aitiqaf from the same evening due to which he was unable to travel and could not appear
personally before the Board on 30.07.2013, and requested that his case may be deferred for next
meeting.,
The Board after considering all the aspects of the case and request of the owner of the company
had made following decision which was also conveyed to the firm accordingly:
The Board decided to defer the case till next meeting of CLB and the
production will remain stopped till the final decision by Central
Licensing Board.
A reminder has been sent to the company by this Authority on 14.11.2013 with the direction to submit
the reply of show cause notice along with the current status of the company in the light of their
letter dated 25.03.2013 for appraisal of Central Licensing Board. The firm in response has
requested to give more time for improvements.
Proceedings:-
The representative of the company was called for personal hearing and the case was placed before the
Central Licensing Board in its 233rd
meeting held on 31.12.2013 for consideration.
Mr. Amin Motiwala, owner of the firm appeared before the Central Licensing Board and pleaded
that they have made all the improvements as advised by the FID and will be ready for re-
inspection at the end of January, 2014.
Decision of CLB:-
The Board after thorough discussion and keeping the facts on records has decided as follows:-
The Board acceded to the request of the company and decided to get the
firm re-inspected by a panel of experts. The panel has to send a
compliance report in this regard to the Chairman, Central Licensing
Board.
74
Agenda Item No. II:
(New Cases of Quality Assurance)
Case No.13:- M/s Munawar Pharma (Pvt) Ltd, Lahore
The inspection of M/s Munawar Pharma (Pvt) Ltd, Lahore was conducted on 25.07.2013 by a
panel comprising Mr. Ajmal Sohail Asif, FID Lahore, Mrs. Majida Mujahid, FID Lahore and Dr.
Akbar Ali, ADC Lahore with reference to investigate the reported allegric reactions took place at
District Head Quarter Hospital, Layyah and to see/verify the GMP compliance of the firm. The
panel had pointed out number of shortcomings in all sections. it had been reported that the
conditions in the manufacturing unit were not in conformity with the conditions of License and
Good Manufacturing Practice (GMP) as laid down under Drugs (Licensing, Registering and
Advertising) Rules, 1976.
Recommendation of the Panel: The panel recommended and directed the firm to stop the
production in all injectable sections (general, steroids, psychotropic/narcotic and small volume
infusion) immediately till further orders.
Action Taken by DRAP: A show cause notice and direction to stop manufacturing in the
Injectable Sections (general, psychotropic/narcotic and small volume infusion) was served on
02.09.2013. The firm in response has submitted a compliance report and requested for re-
inspection of their unit.
Position Explained: On the approval of the Chairman, Central Licensing Board/Director
(QA/Lab Testing & Lic) a following panel was constituted for verifying the GMP compliance.
i) Dr. Ahmad Mahmood Mumtaz, Chairman Quality Control,
Islamabad,
ii) Mr. Nadeem Iqbal, Member Central Licensing Board,
iii) Mrs. Majida Mujahid,Area FID Lahore and
iv) Mr. Ihsan-ul-Haq instead of Mr. Akbar Ali, Area ADC Lahore
The panel inspected the company on 28.10.2013 to check/verify the improvements made by the
company w.r.t the serious shortcomings pointed out by the previous panel in its inspection dated
25.07.2013. The panel dated 28.10.2013 concluded that the company has made improvements in
production area, quality control and willing to abide the inspection imparted by the inspection
teams. The orders of stop production may be withdrawn at the earliest.
The case was placed before the Central Licensing Board for consideration.
Proceedings:
During the course of the proceeding of the CLB, Mr. Moazzam Ali Khan, Director, PQCB, the
representative of the Government of Punjab informed the Board that the company had also been
inspected by the Drug Inspector of Health Department of Government of Punjab. The Drug
Inspector had ordered for stoppage of production in sterile area. The representative of the
Government of Punjab was unable to state regarding the formal report or request by the
Provincial, Quality Control Board, Lahore and/or Health Department, Government of Punjab to
the Central Licensing Board, Islamabad in this regard. The Board was also informed, the law
75
position on the coordination between Federal and Provincial Governments under Section 11 of
Drugs Act, 1976.
Decision of CLB:-
The Board after thorough discussion and keeping the facts on records has decided as follows:-
The Board after considering the inspection report of the panel of experts
constituted by the DRAP, Islamabad agreed the recommendations of the panel
to allow the resumption of production of M/s Munawar Pharma (Pvt) Ltd,
Lahore.
76
Case No.14:- M/s Harmann Pharma (Pvt) Ltd, Lahore
The inspection of M/s Harmann Pharmaceutical Laboratories (Pvt) Ltd, Lahore was conducted
on 03.10.2013 and 04.10.2013 by Mr. Ajmal Sohail Asif, FID Lahore to check and verify the
GMP compliance by the company. During the inspection, the FID has pointed out a number of
major and critical shortcomings and violation GMP under Drugs (Licensing, Registering &
Advertising) Rules, 1976.
The FID concluded that the company was considered to be operating at unsatisfactory level of
compliance with GMP guidelines as per Drugs Act, 1976 and rules framed there under and
directed the firm as under:
i) The firm was directed to stop all kinds of manufacturing activities till the rectification of
the shortcomings and improvement in GMP compliance level.
ii) The firm was advised to recall all the products which were marketed without conducting
the complete test analysis especially the sterile products which were marketed without
performing the sterility test.
iii) The firm was advised either to surrender the Narcotic/Psychotropic products registered in
tablet section or stop production of these products till the provision of separate section.
iv) The firm was advised either to surrender the Steroidal products registered in tablet
section and in ointment/cream section or stop production of these products till the
provision of separate sections.
v) The firm was advised either to surrender the Hormonal product registered in injectable
section or stop production of this product till the provision of dedicated manufacturing
facility.
vi) The firm was advised either to surrender the registrations for manufacturing of eye drops
or stop production of these products till the provision of separate section.
vii) The firm was advised to establish a functional, independent and effective Quality
Assurance department.
viii) The firm was advised to hire adequate and experienced technical staff to carry out the
manufacturing and quality control activities.
ix) The firm was advised to improve the overall conditions of sanitation and hygiene of
production areas and general cleanliness of the unit.
x) The firm was advised to review/update and develop the SOPs for each and every process
being conducted in the premises in connection to manufacturing and QC of products.
xi) The firm was advised to harmonize the practices and procedures with the SOPs and GMP
guidelines and to enforce the strict implementation of the SOPs.
xii) The management of the firm was directed to prepare and submit an action plan in the
light of observations of the inspection with clear time schedule for rectification of the
shortcomings and improvements in the cGMP compliance.
Action Taken by DRAP: A show cause notice and the direction to stop manufacturing in all
sections immediately was served to the company dated 12.11.2013. In response to the inspection
report of FID, the firm has submitted annotated reply. The company has filed a writ petition
against the show cause notice and stop production order. The Honorable High Court has granted
stay to the firm to the extent to stop manufacturing of drugs till next date of hearing against the
show cause notice issued by this Authority on 12.11.2013.
77
The representative of the company has been called for explaining their view point before the
Board, please.
Proceedings:
The representative of the firm informed telephonically to the DDC (QA) that the matter is
still in the court and they are not able to appear before the Board being a subjudice matter.
Decision of CLB:-
The Board deferred the case as the matter is subjudice before the
Honorable Islamabad High Court, Islamabad.
78
Case No.15:- The Searle Company Ltd, Lahore
The inspection of M/s Searle Company Ltd, Lahore was conducted on 21.08.2013 by Mr. Ajmal
Sohail Asif, FID Lahore with reference to see/verify the GMP compliance of the firm. The FID
has pointed out number of shortcomings in all sections. Whereas, it has been reported that the
conditions in the manufacturing unit were not in conformity with the conditions of License and
Good Manufacturing Practice (GMP) as laid down under Drugs (Licensing, Registering and
Advertising) Rules, 1976. The FID particularly mentioned regarding the tablet section which is
as under:
Tablet Section (General):-Manufacturing activities were being conducted in Tablet Section
(General) whereas pervious inspection reports were silent about any formal approval of this
newly established tablet section. Scrutiny of record available in the office of FID revealed that
they had got approval for layout plan expansion to establish Tablet (General), Capsule (general)
and Quality Control Laboratory but neither panel inspection had been conducted to verify the
facilities nor formal approval of Central Licensing Board was granted for grant of additional
sections. They have failed to provide any such approval for allowing them to commence
manufacturing in this section.
Action Taken by DRAP: On the approval of the Chairman, CLB, a show cause notice was
served on 23.09.2013 with the direction to stop manufacturing in tablet section immediately.
The FID had informed that a panel inspection was conducted on 22.10.2013 which was carried
out for the purpose of grant of additional section to the firm.
Reply of the firm:-The firm in their reply to the show cause notice stated that they appreciate
and regard the audit procedure and report of FID. The firm further submitted that there was
always room for improvement; they will keep on striving to fulfill all shortcomings of their
manufacturing facility. They have also requested to facilitate the earliest panel inspection of
tablet section.
The representative of the company was called for personal hearing and the case is placed before
the Central Licensing Board for consideration, please.
Proceedings:-
The representative of the company was for personal hearing in its 233rd
meeting of CLB held on
31.12.2013and the case was placed before the Central Licensing Board for consideration.
Dr. Syed Nadeem Ahmad, CEO and Mr. Muhammad Amir Bashir, Director Technical Operation
of the company appeared before the Board and informed that they have established the facilities
for the manufacturing of tablets in Block II. The panel of experts in the inspection report dated
22.10.2013 have already recommended for approval of section along with the resumption of
production in the tablet section. The panel has commented that the company is GMP compliance.
The representative further informed that they are going to withdraw the capsule section and no
more interested in the capsule dosage form. They seek permission from the Central Licensing
Board for utilizing the facilities for tablet section.
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Decision of CLB:
The Board after considering views of the representatives of the company has
decided the following:
i) The manufacturing in Tablet Section shall remain suspended.
ii) The resumption of production in the tablet section will be allowed after
re-inspection for verification of the cGMP compliance of the company by a
panel constituted by competent authority.
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Case No.16:- M/s Hirra Pharmaceutical Labs, Lahore
The inspection of M/s Hirra Pharmaceutical Labs, Lahore conducted on 27.05.2013 by Mrs.
Majida Mujahid, FID Lahore with reference to see/verify the GMP compliance of the firm.
During inspection, the FID has pointed out number of serious shortcomings/deficiencies in all
sections. The FID had concluded and directed the firm to stop production in vaccine section.
Action taken by the DRAP: A show cause notice was served on 23.09.2013 with the direction
to stop manufacturing in vaccine section immediately. The firm has so far not replied the show
cause notice. A reminder has been sent to the firm on 12.11.2013.
Reply of the firm: The firm has submitted a reply of reminder of show cause notice in their
letter dated 20.11.2013 stating that they are in process of upgradation, renovation in different
sections as pointed out by the area FID during inspection. They will be ready within one month
for re-inspection. They have also submitted that they will inform in writing to the Central
Licensing Board for panel inspection.
The case was placed before the Central Licensing Board for consideration.
Decision of CLB:
The Board after thorough discussion and keeping the facts on records has decided as follows:-
The order of suspension of production in vaccine section will continue till
final decision of CLB. A reminder be served to the company as the company
has not yet informed the CLB for improvements.
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Case No.17:- M/s Medicare Disposable Industries, Lahore
The FID, Lahore (Mr. Ajmal Sohail Asif) inspected the M/s Medicare Disposable Industries,
Lahore on 28.08.2013, with reference to see/verify the GMP compliance of the firm. The FID,
Lahore had pointed out a number of shortcomings in all sections. It had been reported that the
conditions in the manufacturing unit were not in conformity with the conditions of License and
Good Manufacturing Practice (GMP) as laid down under Drugs (Licensing, Registering and
Advertising) Rules, 1976.
Action Taken by DRAP: A show cause notice and direction to stop manufacturing of the
Drugs immediately, was served on 19.09.2013. The firm in response vide their letter dated
24.09.2013 has submitted a compliance report and requested for re-inspection of their unit.
Position Explained: On the approval of the Chairman, Central Licensing Board/Director
(QA/Lab Testing & Lic) the following panel was constituted for verifying the GMP compliance.
i) Dr. Ahmad Mahmood Mumtaz, Chairman Quality Control,
Islamabad,
ii) Mr. Ayaz Ali Khan, Member Central Licensing Board,
iii) Mr. Ajmal Sohail Asif, Area FID, Lahore.
The panel inspected the company on 18.11.2013. The company has made number of
improvements, necessary changes and has positive attitude towards the requirements of cGMP,
in view of this, the panel of inspectors recommends the resumption of production in all sections.
The case was placed before the Central Licensing Board for consideration.
Proceedings:
The representative of the Government of Punjab, Mr. Moazzam Ali Khan, Provincial, Quality
Control Board informed the Central Licensing Board that the company is using corridor for
workers to move across the corridor. This practice of moving of workers across the corridor be
stopped, immediately. The CLB was informed that the corridor is basically used for transferring
of the prepared components of disposable syringes for one building block to the second building
block. The Central Licensing Board was further informed that these companies have been
granted drug manufacturing license and have now became pharmaceutical companies. The
Central Licensing Board was apprised that the Federal Inspector of Drugs have already been
advised to make regular inspection of disposable manufacturing companies. The company, M/s
Medicare Disposable Industries, Lahore has submitted an undertaking on stamp paper that they
will not use the corridor for extra movement of workers.
Decision of CLB:
The Board after thorough discussion and keeping the facts on records has decided as follows:-
i) The Board after considering the inspection report of the panel of experts
agreed the recommendations of the panel to allow the resumption of
production in all sections of M/s Medicare Disposable Industries, Lahore
subject to improvements in corridor as highlighted by area FID.
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Case No.18:- M/s Ahson Drug Company, Tandoadam
The inspection of M/s Ahson Drug Company, Tandoadam conducted on 25.09.2013 by Dr.
Najam-us-Saquib, FID Hyderabad at Karachi with reference to see/verify the GMP compliance
of the firm. During inspection, the FID has pointed out number of serious
shortcomings/deficiencies in all sections. The FID concluded that the firm was not operational at
an acceptable level of compliance with GMP guidelines. The FID has recommended that it is
quite dangerous and health hazardous for the public, that is why the firm was directed to stop
production in all sections immediately.
Action taken by the DRAP: A show cause notice was served on 01.11.2013 by this Authority
with the direction to stop manufacturing of drugs immediately.
Reply of the firm: The firm has submitted a reply in response of show cause notice stated that
they have made improvements as suggested by the FID and requested for re-inspection.
The case was placed before the Central Licensing Board for consideration.
Proceedings:-
The representative of the company was for personal hearing in its 233rd
meeting of CLB held on
31.12.2013and the case was placed before the Central Licensing Board for consideration.
Mr. Abdul Wahab Ansair, Managing Partner and Mr. Manohar Lal, Chief Executive of the
company appeared before the Board and requested that they have made improvements as advised
by the FID. They pleaded that they are ready for inspection.
Decision of CLB:
The Board after thorough discussion and keeping the facts on records has decided as follows:-
The company, M/s Ahson Drug Company, Tandoadam be re-inspected by a
panel of experts within one month. The production of the company shall
remain suspended and the report will be submitted before CLB for
approval.
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Case No.19: M/s Epoch Pharmaceuticals, Karachi
The inspection of M/s Epoch Pharmaceuticals, Karachi conducted on the directions of 239th
meeting of Drug Registration Board vide letter No.F.3-2/2013-Reg-II (M-328) dated 07.10.2013
for the purpose of grant of registrations of certain drugs. A panel comprising of Mr. Amanullah
Khan, Director DTL Quetta/Member DRB and Mr. Abdul Rasool Shaikh, FID Karachi
conducted the inspection on 01.11.2013. The panel rejected the recommendations for registration
of the products applied by the company. The panel also observed serious
shortcomings/deficiencies and GMP violations in all sections. The matter was referred to QA
Section for evaluation/verification of the GMP compliance by the company.
Action taken by the DRAP:
i) A show cause notice was served on 19.11.2013 by this Authority with the
direction to stop production in tablet, capsule and sterile injection section with
immediate effect.
ii) A following panel was constituted on 19.11.2013 for conducting the inspection of
the firm in all sections excluding tablet, capsule and sterile injection sections
mentioned in the show cause notice dated 19.11.2013.
a) Syed Jawed Yousaf Bukhari, Member Central Licenisng Board.
b) Dr. Muhammad Tanweer Alam, DDG (E&M) Karachi.
c) Mr. Abdul Rasool Shaikh, Area FID, Karachi.
d) Dr. Shoaib Ahmad, ADC Karachi
The aforesaid panel inspected the company on 11.12.2013 and concluded as under:
The panel identified some serious GMP lapses mentioned under each heading and critical observations
of high risk. The panel unanimously decided that the firm should voluntarily discontinued their
production activities till compliance of all the critical observations in following production areas.
Sterile cephalosporin
Oral cephalosporin,
Oral penciling and
Ophthalmic sections
In other sections, the company may continue their manufacturing processes as those were minor
shortcomings which the management agreed to rectify within 15 days. The panel also observed
that the other sections (tablet, capsule and sterile injection sections) were under renovation and
overhauling and no production was seen during their visit.
The representative of the company was called for personal hearing and the case is placed before the
Central Licensing Board for consideration, please.
Proceedings:
The representative of the company was called for personal hearing in its 233rd
meeting of CLB held on
31.12.2013. Mr. Saleem Managing Director appeared before the Board. The representative
submitted that they have made improvements and ready for inspection. The Board was informed
that the company is involved in the manufacturing of sterile cephalosporin and other sensitive
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products and at the time of inspection by the panel, tablet, capsule and sterile injection sections
were under renovation and overhauling and no production was seen during their visit. The panel
identified some serious GMP lapses in the Sterile cephalosporin, Oral cephalosporin, Oral
penicillin and Ophthalmic sections.
Decision of CLB:-
The Board after considering views of the representatives of the company has decided the
following:
The production of the company will remain suspended till the final approval
of CLB. In the meanwhile the FID has to verify the production activities
and progress made by the company by making frequent inspections/visits at
a practicable time intervals.
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Case No.20: M/s Nawan Laboratories (Pvt) Ltd, Karachi
The inspection of M/s Nawan Laboratories (Pvt) Ltd, Karachi was conducted on 01.11.2013 on
the directions of Drug Registration Board in its 239th
meeting for investigating the reasons
manufacture and sale of substandard, “Paemactin Drench” and to identify the problems and
confirm the actions take by the firm. A panel comprising of Mr. Amanullah Khan, Member
DRB/Director DTL Quetta, Dr. Tanweer Alam, DDG (E&M) Karachi and Mr. Abdul Rasool
Shaikh, FID Karachi had also observed the GMP compliance level of the firm. During the
inspection, the panel pointed out number of gross violations of GMP. The matter was referred to
QA Section for evaluation/verification of the GMP compliance by the company.
Recommendations of the panel:-
The panel had reported that the overall GMP compliance of the firm was non-compliant. Around
115 bottles of suspension Paemactin were recovered/recall from the market and seen kept in
finished good stores. The root-caused still has not been identified. The panel recommended that
due to gross GMP violation of the firm, the production in all solid/dosage and liquid veterinary
section be stopped. The panel also sealed the veterinary production area of the firm for public
interest.
The FID telephonically confirmed that the veterinary production area and only non-sterile area was
sealed because the scope of the inspection was specific/limited, so other manufacturing areas
could not been inspected.
Action taken by the DRAP:
i) A show cause notice was served on 19.11.2013 by this Authority with the direction
to stop production in solid dosage form of veterinary production area including
liquid veterinary section with immediate effect.
ii) A following panel was also constituted on 19.11.2013 conducting the inspection in
other areas which were not inspected in previous inspection to check the overall GMP
compliance:
a) Syed Jawed Yousaf Bukhari, Member Central Licensing Board.
b) Director CDL, Karachi.
c) Chief Drug Inspector, Sindh.
d) Area FID, Karachi.
On the request of the company, the aforesaid panel has not yet inspected the company. The company in
their reply however, has submitted that:
i) To de-seal/re-open the area so as to remove the manageable inadequacies which has
been overlooked inadvertently.
The company further stated that it is only possible that the area may be opened so that they
may start upgrading and rectify the deficiencies.
ii) To extend the panel inspection since they are in the phase of biannual internal cGMP
audit by their internal inspection team, the inspection may be extended till late
December, 2013 or early January, 2014.
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Proceedings:
The representative of the company was called for personal hearing in its 233rd
meeting of CLB
held on 31.12.2013. Mr. Naseer Ahmad Awan, Managing Director appeared before the Board.
The representative submitted that they have made lot of improvements and ready for inspection.
The representative further submitted that the section which was sealed by the team constituted by
Drug Registration Board may be de-sealed so that changes and up-gradation at par with cGMP
compliance be carried out. The representative has explained that he himself requested the panel
of inspector for the grant of time so that the inspection of the company be carried out after they
completed all the renovation and up-gradation.
Decision of CLB:
The Board after considering views of the representatives of the company has decided the
following:
i) The directions to FID to de-seal the area sealed by the panel of
inspectors constituted by Drug Registration Board, so that the company
may make appropriate up-gradation/improvements.
ii) On getting the compliance report from the company within one month,
the same panel already constituted for other areas will inspect all the
sections including the area de-sealed for verification of improvements
made by the company.
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